Zest Dental CHAIRSIDE User manual

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Instructions for Use
Zest CHAIRSIDE® Denture Prep and Polish Kit
IMPORTANT: This document contains the most current Instructions for Use. Please read and retain.
PRODUCT DESCRIPTION
The Zest CHAIRSIDE Denture Prep and Polish Kit contains the necessary instruments to prepare and
finish an overdenture for pickup of a LOCATOR® or SATURNO® attachment. The system includes a recess
bur, undercut bur, vent hole bur, trim bur, grind bur, and polisher.
INDICATIONS FOR USE
The Zest CHAIRSIDE Denture Prep and Polish Kit is intended to prepare and polish full and partial acrylic
dentures as part of a chairside or laboratory procedure.
CAUTION
Federal (USA) law restricts this device to sale by or on the order of a licensed dentist.
MULTI-USE DEVICES
CHAIRSIDE Denture Prep and Polish Kit are multi-use devices and are provided non-sterile. Reusable
tools and instruments must be cleaned and sterilized prior to use or reuse on patients. Reuse of a multi-
use devices without cleaning and sterilization may cause harm to the patient in the transfer of blood,
tissue, or saliva that may contain infectious disease.
PREPARATION
•Impurities need to be removed from the products directly after use (within two hours
maximum). To do so, use running water or an FDA approved and/or CE Marked disinfectant
solution. The disinfectant’s effectiveness should be established, suitable, and compatible with
the instruments.
CLEANING INSTRUCTIONS
•Place the instruments in the cleaning bath for the prescribed contact time and concentration,
take care that the instruments do not contact each other.
•In case of severe contamination of the instrument, it is recommended to use an ultrasonic bath
for cleaning.
•The Bur Block must be cleaned and disinfected without instruments loaded.
•The Bur Block is not suitable for cleaning using a thermo disinfector (disinfector RDG).
•Remove instruments from the cleaning solution and rinse for at least 3 minutes with tap water.
•Remove excess moisture from the components with a clean, absorbent, and non-shedding wipe.
RECOMMENDED STERILIZATION INSTRUCTIONS

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•All components and instruments are supplied NON-STERILE.
•Check instruments for damaged surfaces, chipped off edges, deformations and eliminate
damaged instruments. Products that are still contaminated need to be cleaned and disinfected
until all visible contaminants have been removed.
•Arrange the cleaned and disinfected instruments in the dedicated bur block. Wrap the bur block
using disposable sterilization packaging and/or sterilization containers. Sterilize the assembled
bur block according to the parameters listed in the following table:
Gravity Autoclave
Pre-Vacuum Autoclave
Temperature
132°C
132°C
Exposure Time
25 minutes
4 minutes
Dry Time
30 minutes
20 minutes
WARNINGS AND PRECAUTIONS
•The use of this or any dental restorative product requires that the clinician and other specialists be
thoroughly familiar with the use and application of these instruments. They must also be familiar
with the instruments and kit sterilization requirements.
•Care should be taken in choosing the operating speed and force applied to instrument during use to
avoid damaging the instrument or work piece due to excessive heat generation.
•Improper use of instruments may contribute to premature wear of the instruments, lead to poor
results and pose a danger to the operator.
•The Polisher is for single use only in cases where residual blood and/or saliva are present.
•The Kit and individual instruments are packaged NON-STERILE and MUST BE properly cleaned,
disinfected, and sterilized per instructions below prior to use.
•Refer and strictly adhere to the manufacturers’ instructions for use for the reaction time and
suitability of disinfectants and detergents.
DIRECTIONS FOR USE - DENTURE PREPARATION PROCEDURES
The steps below are guidelines to help process the dentures for implant-retained restorations:
1. Use the Recess Bur to create a void in the denture. Use the indicators on the bur as shown below
to create the proper recess depth for the LOCATOR and SATURNO Cap.
2. It is recommended that you use the Undercut Bur to create an undercut in the recess which
enhances the mechanical retention of the pick-up material to the prosthesis. The Undercut Bur
can also be used to create additional clearance in the recess, if needed.
3. Use the Vent Bur to create a small hole through the denture recess, which enables the visibility of
the Denture Cap and allows for excess pick-up material to flow out.
4. Use the Trim Bur to carefully trim the flanges and any rough edges on the denture, if needed.
5. Use the Grind Bur to carefully trim around the attachment pick-up material, if needed.

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6. Use the Polisher on all rough edges to create a smooth denture surface.
Recommended Speeds:
Zest
Code
Application
Recommended speed rpm
Maximum speed rpm
09577
Undercut
20,000
50,000
09578
Vent
18,000
50,000
09579
Trim
20,000
35,000
09576
Recess
18,000
30,000
09583
Grind
20,000
35,000
09580
Polish
7,000
12,000
No coolant is needed during use.
STORAGE AND HANDLING
The Zest CHAIRSIDE Prep and Polish Kit in its undamaged, original packaging is not subject to any special
considerations for storage or handling (during transport and storage).
DISPOSAL
Dispose of used devices which pose a risk of infection according to facility clinical waste procedures and
applicable local and state regulations.
NOTICE TO USERS IN THE EUROPEAN UNION
Any serious incident that has occurred in relation to the device(s) in which this Instructions for Use
applies should be reported to the manufacturer identified in this Instructions For Use and the
competent authority of the Member State in which the user and/or patient is established.
DEFINITIONS OF SYMBOLS
The following symbols may appear on the product packaging or labeling.
SYMBOL
TITLE
EXPLANATORY TEXT
STANDARD
REFERENCE
Manufacturer Indicates the medical device
manufacturer EN ISO 15223-1 5.1.1
Catalogue Number
Indicates the manufacturer’s catalogue
number so that the medical device can
be identified
EN ISO 15223-1 5.1.6
Batch Code
Indicates the manufacturer’s batch code
so that the batch or lot can be identified EN ISO 15223-1 5.1.5
Consult Instructions
for Use
Indicates the need for the user to
consult the instructions for use EN ISO 15223-1 5.4.3

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SYMBOL
TITLE
EXPLANATORY TEXT
STANDARD
REFERENCE
Non-Sterile Indicates a medical device that has not been
subjected to a sterilization process EN ISO 15223-1 5.2.7
Date of Manufacture
Indicates the date when the medical
device was manufactured.
EN ISO 15223-
15.1.3
European Mark of
Conformity
Indicates device is in conformance with
Medical Device Regulation EU 2017/745
MDR EU
2017/745 Annex V
Rx only Federal law restricts this device to sale
by or on the order of a dentist only
US CFR
Title 21
801.15(c)(1)
(i)(F)
Quantity
Indicates the number of items within the
package N/A N/A
Unique Device
Identifier
Indicates as containing Unique Device
Identifier information ISO 15223-1 5.7.10
Medical device Indicates the item is a medical device ISO 15223-1 5.7.7
Do not re-use
Indicates a medical device that is
intended for one single use only
ISO 15223-1
5.4.2
Distributor
Indicates the entity distributing the
medical device in the locale
ISO 15223-1
5.1.9
Zest Anchors, LLC JOTA AG Rotary Instruments
2875 Loker Avenue East Hirschensprungstrasse 2
Carlsbad, CA 92010 USA 9464 Rüthi, Switzerland
www.zestdent.com Made in Switzerland
[phone]
L8114-ZD Rev D 2021-09
CHAIRSIDE and ZEST are registered trademarks and Zest
Dental Solutions is a trademark of ZEST IP Holdings, LLC
U.S. Patents: Refer to www.zestdent.com/patents