KometaBio Smart Dentin Grinder User manual

–
Smart Dentin
Grinder™
User Guide
Tissu e Engineerin g Bon e Graftin g P rocess
Version 1.2

Smart Dentin Grinder User Guide
About This Guide
2
Thank you for purchasing the Smart Dentin Grinder™, which enables you to create a
patient’s own autologous bone graft within less than 15 minutes!
Thanks to this solution, extracted teeth are no longer considered to be clinical waste.
Extracted teeth can now be used as an autologous bone graft, which is the golden
standard of grafting. With Smart Dentin Grinder™, a few short steps easily transform
an extracted tooth into a sterile and clean dentin particulate ready for grafting.
We are certain that this autologous graft will provide you with optimal results.
This user guide is intended for dental practitioners. It describes how to use the Smart
Dentin Grinder.
• Chapter 1, Introducing the Smart Dentin Grinder Process, page 7, introduces the
Smart Dentin Grinder and describes its components and how it works.
• Chapter 2, Using the Smart Dentin Grinder, page 13, describes how to transform
an extracted tooth into a sterile and clean particulate dentin ready for grafting.
• Appendix A, Specifications, page 27, describes the specifications for the Smart
Dentin Grinder.
• Appendix B, Labeling, page 28, shows the label that appears on the Smart Dentin
Grinder.

Important Notice
3
Important Notice
Copyright © 2013 by Kometa Bio International. All rights reserved.
All intellectual property rights in this publication are owned by Kometa Bio International. and
protected by applicable copyright laws and international treaty provisions. Kometa Bio
International. retains all rights not expressly granted. No part of this publication may be reproduced
in any form whatsoever or used to make any derivative work without prior written approval by
Kometa Bio International.
Kometa Bio International. reserves the right to revise this publication, and/or make improvements or
changes in the product(s) and/or the program(s) described in this documentation at any time without
prior notice. The information in this document is provided in good faith. However, it is provided without
any w a rra n ty that it is accurate or complete and on the express understanding that Kometa Bio
International. shall have no liability whatsoever to other parties in any way arising from or relating to
the information or its use.
Any product described in this publication is furnished under its own license agreement.
All other trademarks or registered trademarks are the property of their respective owners.
Date: 05/2013
Document #: 13-10-01
Document Version: 1.0
Device Version: 1.1
Patent Pending No. US61/752,453
CE Representative: Mr. Kfir Atias
2 Devonshire Place W16HG
London, England
Telephone: [phone]

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Smart Dentin Grinder User Guide
Table of Contents
About This Guide.................................................................................................... 1
Important Notice.................................................................................................... 3
Table of Figures...................................................................................................... 5
Documentation Conventions ....................................................................... 5
Safety Information ................................................................................................. 6
Chapter 1: Introducing the Smart Dentin Grinder Process........................................ 7
What is the Smart Dentin Grinder? ................................................................. 7
Device Intended Use ................................................................................ 7
Indications for Use.......................................................................................... 7
Contraindications ........................................................................................... 7
Smart Dentin Grinder Components.................................................................... 8
Sterile Disposable Chamber ........................................................................ 9
Basic Cleansing Solution and Containers ................................................... 10
Hot Plate................................................................................... ................. 10
How Does the Smart Dentin Grinder Work? ..................................................... 11
Step 1, Using the Patient’s Own Teeth....................................................... 11
Step 2, Grinding the Teeth ......................................................................... 11
Step 3, Sterilizing the Particulate ............................................................... 12
Chapter 2: Using the Smart Dentin Grinder ............................................................13
Workflow Overview....................................................................................... 13
Step 1, Preparing the Teeth........................................................................... 14
Step 2, Preparing the Smart Dentin Grinder ................................................. 14
Step 3, Placing the Teeth in the Smart Dentin Grinder ................................. 17
Step 4, Configuring the Smart Dentin Grinder .............................................. 18
Step 5, Grinding the Teeth............................................................................. 20
Step 6, Cleansing the Particles ...................................................................... 21
Step 7, Drying the Particulate........................................................................ 23
Appendix A: Specifications ....................................................................................27
Appendix B: Labeling............................................................................................28

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Table of Figures
Table of Figures
Figure 1: Smart Dentin Grinder Components ...............................................................................................8
Figure 2: Sterile Disposable Chamber ...........................................................................................................9
Figure 3: Grinding Blade and Particulate Si
eve .............................................................................................9
Figure 4: Particulate Drawer
Compartments ..............................................................................................10
Figure 6: Using the Smart Dentin Grinder –Workflow Dia
gr a m .................................................................13
Figure 7: Attaching the
Chamber ................................................................................................................15
Figure 8: Aligning the Arrows......................................................................................................................15
Figure 9: Chamber is
Locked .......................................................................................................................16
Figure 10: Switching On the Smart Dentin Grinder.....................................................................................16
Figure 11: Power Indicator..........................................................................................................................16
Figure 12: Removing the Chamber Cap ......................................................................................................17
Figure 13: Placing the Teeth in the Smart Dentin
Grinder ..........................................................................17
Figure 14: Closing the Chamber Cap...........................................................................................................18
Figure 15: Grinding for 3 S
ec onds...............................................................................................................19
Figure 16: Sorting for 20 Seconds ...............................................................................................................19
Figure 17: Pulling Out the D
r a wer s.............................................................................................................21
Figure 18: Pulling Out the Top Drawer
Compartment ................................................................................21
Figure 19: Harvesting the Implantable Particles .........................................................................................22
Figure 20: Hot Plate ....................................................................................................................................23
Figure 21: Smart Dentin Grinder Label .......................................................................................................28
Documentation Conventions
NOTE:
Notes provide additional important information.
TIP:
Tips provide shortcuts or special guidance that may enable optimal performance.
WARNING!
Warnings indicate conditions or practices that could result in death or serious injury.
It may also describe potential serious adverse reactions and safety hazards.
CAUTION:
Caution indications relate to conditions or practices that are potentially hazardous
that may result in minor or moderate injury to the user or damage to the equipment
or other property. Caution indications may also be used to indicate practices
necessary for effective use of the device.

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Smart Dentin Grinder User Guide
Safety Information
WARNINGS!
Adhere to the following warnings and safety information for the use of this device:
• The Smart Dentin Grinder must only be used with its original parts.
• No modification of the Smart Dentin Grinder is permitted.
• The Smart Dentin Grinder must only be operated in accordance with the
instructions provided in this user guide and for the purpose described in this
user guide.
• Keep the Smart Dentin Grinder away from heat or open flame.
• To avoid electric shock or device malfunction, liquids must not be allowed to
enter the device.
• Do not plug in the Smart Dentin Grinder while barefoot or with wet hands.
• Do not use the Smart Dentin Grinder in an explosive environment or in the
presence of flammable anesthetics or gases.
• Do not use the Smart Dentin Grinder in an oxygen-rich environment.
• The Smart Dentin Grinder should not be operated when there is any visible
physical damage, such as cracks, breaks and so on.
CAUTIONS:
• This device is not defibrillation proof.
• The device is intended for non-continuous operation.
• Storage and transportation temperature is between -5°C to +55°C.
• The Smart Dentin Grinder must only be serviced by an authorized representative.

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1 Introducing the Smart Dentin
Grinder Process
This chapter introduces the Smart Dentin Grinder™ and describes its components
and how it works.
What is the Smart Dentin Grinder?
The Smart Dentin Grinder provides an innovative solution for autologous dentin
grafting. It enables you to convert extracted teeth into a bacteria-free particulate
dentin ready for transplant within less than 30 minutes.
Device Intended Use
The Smart Dentin Grinder grinds extracted teeth into particles and sorts these
particles according to size. This process creates bacteria-free sterile particulate that is
ready for autologous tissue engineering by grafting it into fresh sockets and bone
defects.
Indications for Use
• The Smart Dentin Grinder is intended to be used by dental practitioners.
• The Smart Dentin Grinder is to be used for patients that:
Have one or more non-essential teeth that are specified to be extracted for
autologous grafting by a dentist.
Require bone grafts.
Contraindications
• Teeth that have undergone root canal fillings should be discarded and not used
for grafting.

Smart Dentin Grinder User Guide
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Smart Dentin Grinder Components
The following lists the contents of the Smart Dentin Grinder package.
WARNING!
Check the package contents for damage. If any of the contents of the package are
damaged, do not use the Smart Dentin Grinder and return it to your supplier.
Figure 1: Smart Dentin Grinder Components
Each of the components of the Smart Dentin Grinder is described below:
• Sterile Disposable Chamber, page 9
• Cleansing Solution and Containers, page 10
• Hot Plate, page 10
ParticulateDrawer
Operation panel
Sterile Disposable
Chamber

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Smart Dentin Grinder User Guide
Sterile Disposable Chamber
The Smart Dentin Grinder is provided with three sterile disposable chambers, each of
which must only be used for a single patient during a single session. Each chamber is
provided in a sterilized, sealed packaging.
Figure 2: Sterile Disposable Chamber
Each disposable chamber has a see-through cap. When the cap is open, you can see
the grinding blade and particulate sieve, as shown below:
Figure 3: Grinding Blade and Particulate Sieve
Multi-compartment
Drawer
Removable see-
through cap
Grinding Blade and
Strainer

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The Particulate Drawer has two compartments (sub-drawers), as shown below:
Bottom drawer for
unusable particulate
Top drawer for usable
particulate
Figure 4: Particulate Drawer Compartments
NOTE:
Contact your local distributor when you need more sterile disposable chambers.
Basic Cleansing Solution and Containers
The Smart Dentin Grinder package is provided with a bottle of cleansing solution and
three containers to be used during the cleansing process.
Store the cleansing solution at room temperature. Contact your local distributor
when you need more cleansing solution or containers.
WARNING!
Do not reuse the same chamber, solution or containers for different patients or for
the same patient in different sessions. The cleansing solution bottle contains enough
solution for a few patients.
WARNING!
The cleansing solution contains high pH (very basic) Sodium hydroxide in ethanol.
Wear eye protection while handling the cleansing solution.
Hot Plate
After the particulate has been rinsed thoroughly with saline and the saline has been
decanted leaving wet particulate, you can use the hot plate to dry the particulate.
The hot plate can be reused as needed. Be careful!! The glass container is very hot,
do not touch it!

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Smart Dentin Grinder User Guide
How Does the Smart Dentin Grinder Work?
The Smart Dentin Grinder grinds a patient’s own teeth into dentin particulate,
separates the particulate into specific sized particles and then provides a cleansing
solution that leaves the dentin particles bacteria-free. This procedure transforms any
patient’s tooth into a sterile particulate dentin that is grafting bio-material for a
highly predictable autologous graft.
The following provides an overview of how the Smart Dentin Grinder works. Detailed
operation instructions are provided in Chapter 2, Using the Smart Dentin Grinder on
page 13.
Step 1
Step 2
Step 3
Using the Patient’s Own Teeth
Grinding the Teeth
Sterilizing the Particulate
Page 11
Page 11
Page 12
Figure 5: Stages of the Smart Dentin Grinder Process
Step 1, Using the Patient’s Own Teeth
One or more of the patient’s own teeth are extracted in the usual manner and then
cleaned.
Step 2, Grinding the Teeth
The Smart Dentin Grinder is specially designed for grinding teeth into particulate
dentin. It grinds the teeth into particles and then sorts them according to size.
Dentin particles of suitable size for implanting (between 300 and 1,200 microns) are
automatically stored in the Smart Dentin Grinder’s top drawer compartment.

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Smart Dentin Grinder User Guide
Large particles can be reground in order to obtain more particles of the proper size
(between 300 and 1,200 microns).
Extremely small dentin particles (below 200 microns) fall into its bottom drawer
compartment for disposal. Efficiency is approximately 95%, meaning that typically
95% of the extracted tooth can be used for dentin bone grafting.
The Smart Dentin Grinder enables you to configure the grinding time of the teeth and
the sorting time of the particulate.
NOTE:
Grinding speed and vibration intensity are predefined and cannot be changed.
Step 3, Sterilizing the Particulate
The Smart Dentin Grinder process provides a special dentin particulate chemical
cleanser that dissolves all the organic debris, resulting in a bacteria-free sterile
particulate ready for transplanting into fresh sockets and bone defects.

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2 Using the Smart Dentin
Grinder
This chapter describes how to transform an extracted tooth into a sterile and clean
particulate dentin ready for grafting.
Workflow Overview
The following describes the workflow for using the Smart Dentin Grinder.
Step 1
Step 2
Step 3
Step 4
Step 5
Preparing the Teeth
Preparing the Smart Dentin Grinder
Placing the Teeth in the
Smart Dentin Grinder
Configuring the Smart Dentin Grinder
Grinding the Teeth
Page 14
Page 14
Page 17
Page 18
Page 20
Step 6 Cleansing the Particulate Page 21
Step 7 Drying the Particulate Page 23
Figure 6: Using the Smart Dentin Grinder –Workflow Diagram

Smart Dentin Grinder User Guide
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Step 1, Preparing the Teeth
Only teeth that have undergone root canal fillings are not suitable. All other teeth
can be used.
WARNING!
Do not use teeth that have root canal fillings.
► To handle the extracted teeth:
1 Extract one or more of the patient’s own teeth in the usual manner. This should
be done during the same treatment session as the grinding, not before.
2 Use a tungsten bur to remove all cavities and artificial material from the
extracted tooth, so that only the clean tooth dentin remains.
Artificial material to be removed may include fillings, crowns and any prosthetic
materials.
3 Remove all surface debris, especially on the root.
Step 2, Preparing the Smart Dentin Grinder
This step describes how to prepare the Smart Dentin Grinder for a procedure.
CAUTION:
The Smart Dentin Grinder vibrates and therefore must be kept on a stable surface
away from the table’s edges.
CAUTION:
Each chamber comes in sterilized packaging. Do not open its packaging before this
point.
WARNING!
Each sterile disposable chamber must only be used for a single patient and only once.

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Smart Dentin Grinder User Guide
► To prepare the Smart Dentin Grinder:
1 Place the Smart Dentin Grinder on a flat and stable surface or tabletop.
2 Plug in the Smart Dentin Grinder into a standard electrical outlet.
3 Open the chamber’s sterile packaging.
4 Put the chamber on the top of the Smart Dentin Grinder, as shown below:
Figure 7: Attaching the Chamber
5 Align the small arrow on the chamber with the one in the center of the grinder,
as shown below:
Figure 8: Aligning the Arrows
Aligning the Arrows

Smart Dentin Grinder User Guide
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6 Turn the chamber counterclockwise to lock it in position. When locked, the LOCK
indicator arrow on the chamber is to the right of the arrow in the center of the
grinder.
Figure 9: Chamber is Locked
7 Switch on the Smart Dentin Grinder, as shown below:
Figure 10: Switching On the Smart Dentin Grinder
The POWER indicator should light up on the operation panel, as shown below:
Figure 11: Power Indicator

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Smart Dentin Grinder User Guide
Step 3, Placing the Teeth in the Smart Dentin
Grinder
The Smart Dentin Grinder is a specially designed for grinding teeth into particulate
dentin. The instructions below can be used for between one and six teeth at once.
NOTE:
If you wish to process more than six teeth for the same patient in the same session,
then simply perform this entire process on a few teeth at a time.
► To grind the teeth:
1 Remove the cap of the sterile disposable chamber, as shown below:
Figure 12: Removing the Chamber Cap
2 Please dry the teeth with air before placing them in the grinding chamber!
3 Place the prepared teeth on the grinding sieve next to the blades, as shown
below:
Figure 13: Placing the Teeth in the Smart Dentin Grinder
The teeth must have been prepared, as described in the Step 1, Preparing the
Teeth section on page 14.

Smart Dentin Grinder User Guide
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4 Close the chamber cap and twist it counterclockwise so that it clicks into place.
Figure 14: Closing the Chamber Cap
NOTE:
The chamber cap has a safety latch so that the Smart Dentin Grinder stops
immediately when the cap is open.
Step 4, Configuring the Smart Dentin Grinder
The Smart Dentin Grinder enables you to configure its grinding time and sorting time.
TIP:
We highly recommend grinding less time as opposed to more time. The reason is that
grinding too long produces unusable particulate (particles of less than 200 microns).
Therefore, it is much preferable to grind less time and then to repeat the grinding
process by pressing the START button again.
NOTE:
The Smart Dentin Grinder retains the latest configuration that you set (as described
on the next page) unless it is powered off.

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Smart Dentin Grinder User Guide
► To configure the Smart Dentin Grinder:
1 Grinding time refers to the number of seconds that the Smart Dentin Grinder
spins its blade in order to break down the dentin material into particles.
To configure Grinding Time:
Press the GRIND button. The GRIND indicator lights up.
Press the UP and/or the DOWN button as many times as needed in order to set
the preferred Grinding Time.
We recommend setting grinding time to 3 seconds, as shown below:
Figure 15: Grinding for 3 Seconds
2 Sorting Time refers to the number of seconds that the Smart Dentin Grinder
vibrates in order to filter the particles through the grinder’s sieve and the
removable chamber’s drawers.
To configure the Sorting time, in seconds:
Press the SORT button. The SORT indicator lights up.
Press the UP and/or the DOWN button as many times as needed in order to
set the preferred Sorting Time.
We recommend setting sorting time to 20 seconds, as shown below:
Figure 16: Sorting for 20 Seconds
TIP:
To display the currently configured Grinding Time, simply press the GRIND button.
To display the currently configured Sorting Time, simply press the SORT button.

Smart Dentin Grinder User Guide
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Step 5, Grinding the Teeth
► To start the Smart Dentin Grinder:
1 Press the START button to start the grinding process. The sorting (vibrating)
Process starts automatically afterwards.
Dentin particles smaller than 1,200 microns fall into the top drawer.
The bottom of the top drawer is mesh that allows particles smaller than 200
microns to fall into the bottom drawer. These particles are to be disposed of.
This leaves particles of between 300 to 1,200 microns in the top drawer. The
Resulting particulate dentin in this top drawer may be two to three times the
Volume of the original root.
2 Click the START button again to grind for another 3 seconds and to sort for
another 20 seconds.
3 If large pieces are left in the grinding chamber, then press the START button
again to grind for another 3 seconds and to sort for another 20 seconds.
If the teeth appear to be ground already, but the particulate has simply not fallen
through the grinding sieve holes, then set the Grinding to 0 and then press the
START button again to only perform the sorting procedure.