Zest Dental CHAIRSIDE

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Summary

Zest CHAIRSIDE Denture Prep and Polish Kit Instructions

Product Description

Details the instruments in the kit for preparing and finishing overdentures for attachment pickup.

Indications for Use

Specifies the intended use of the kit for preparing and polishing acrylic dentures chairside or in a lab.

Caution

Highlights that US federal law restricts sales to licensed dentists.

Multi-Use Devices

Explains that kit components are reusable and require cleaning/sterilization to prevent patient harm.

Preparation

Instructs on removing impurities from products after use using running water or approved disinfectant.

Cleaning Instructions

Details procedures for cleaning instruments, including using baths and ultrasonic cleaning.

Recommended Sterilization Instructions

Provides parameters for sterilizing the assembled bur block using autoclaves.

Sterilization Parameters

Autoclave Sterilization

Lists temperature, exposure, and dry times for Gravity and Pre-Vacuum autoclaves.

Warnings and Precautions

General Warnings

Emphasizes user familiarity with instruments, sterilization, and avoiding excessive heat.

Specific Precautions

Notes the polisher is for single use with blood/saliva and adherence to manufacturer instructions.

Denture Preparation Procedures

Step-by-Step Guide

Outlines using Recess, Undercut, Vent, Trim, and Grind Burs for denture preparation.

Recommended Speeds and Handling

Instrument Speed Recommendations

Provides recommended and maximum speeds for each Zest Code instrument.

Storage and Handling

States no special considerations for storage or handling of undamaged original packaging.

Disposal Guidelines

Instructs to dispose of used devices according to facility clinical waste procedures.

European Union Notice

Requires reporting serious incidents to the manufacturer and competent authority.

Symbols Definition

Common Symbols

Explains symbols like Manufacturer, Catalogue Number, Batch Code, and Consult Instructions.

Device Labeling Symbols

Sterilization and Regulatory Symbols

Defines symbols for Non-Sterile, Date of Manufacture, CE Mark, Rx only, Quantity, UDI, Medical Device, Do not re-use, and Distributor.

The Zest CHAIRSIDE® Denture Prep and Polish Kit is a multi-use dental device designed for the preparation and finishing of full and partial acrylic dentures. This system facilitates the chairside or laboratory procedure for picking up LOCATOR® or SATURNO® attachments. The kit is provided non-sterile and requires proper cleaning and sterilization before initial use and any subsequent reuse on patients to prevent the transfer of blood, tissue, or saliva that may contain infectious diseases.

Function Description

The primary function of the Zest CHAIRSIDE® Denture Prep and Polish Kit is to enable dentists and dental professionals to prepare and polish dentures for the integration of implant-retained restorations. The kit comprises a set of specialized instruments, each designed for a specific step in the denture modification process:

Recess Bur: This bur is used to create a void or recess within the denture. It features indicators that guide the user in achieving the correct depth for accommodating LOCATOR® and SATURNO® Caps, ensuring a precise fit for the attachment.
Undercut Bur: The Undercut Bur is employed to create an undercut within the previously formed recess. This undercut is crucial for enhancing the mechanical retention of the pick-up material, ensuring a secure bond between the attachment and the prosthesis. It can also be utilized to create additional clearance in the recess if necessary.
Vent Bur: This instrument is designed to create a small vent hole through the denture recess. The vent hole serves two purposes: it allows for visibility of the Denture Cap during the pick-up process and facilitates the outflow of any excess pick-up material, preventing hydraulic pressure buildup and ensuring a clean fit.
Trim Bur: The Trim Bur is used for carefully trimming the flanges and any rough edges on the denture. This ensures a smooth and comfortable fit for the patient and improves the overall aesthetics of the prosthesis.
Grind Bur: This bur is utilized for carefully trimming around the attachment pick-up material after it has set. This step refines the contours around the attachment, ensuring a smooth transition and preventing any sharp edges that could irritate the patient's soft tissues.
Polisher: The Polisher is the final instrument in the kit, used to smooth all rough edges on the denture surface. This step is essential for achieving a highly polished and comfortable denture, enhancing patient satisfaction.

Usage Features

The Zest CHAIRSIDE® Denture Prep and Polish Kit is designed for ease of use in both chairside and laboratory settings. The instruments are intended to be used with dental handpieces, and specific recommended speeds are provided for each bur and the polisher to optimize performance and prevent damage to the instrument or workpiece.

Guided Recess Creation: The Recess Bur includes visual indicators to help clinicians achieve the precise depth required for LOCATOR® and SATURNO® Caps, simplifying the initial preparation step.
Enhanced Retention: The Undercut Bur's design specifically addresses the need for mechanical retention, ensuring a strong and durable bond for the pick-up material.
Visibility and Material Flow: The Vent Bur's function in creating a small hole improves visibility during the attachment placement and allows for controlled excess material expulsion, contributing to a cleaner and more accurate procedure.
Refinement and Comfort: The Trim Bur and Grind Bur allow for meticulous shaping and contouring of the denture, addressing both functional and aesthetic aspects by removing rough edges and excess material.
Smooth Finish: The Polisher is crucial for the final finishing step, ensuring that all surfaces are smooth and comfortable for the patient, which is vital for long-term wearability.
Speed Recommendations: The manual provides clear recommended operating speeds for each instrument (Undercut, Vent, Trim, Recess, Grind, and Polish burs). These guidelines are critical for optimal performance, preventing excessive heat generation, and extending the lifespan of the instruments. No coolant is required during use, simplifying the procedure.
Multi-Use Design: All instruments, except for the Polisher (which is single-use if residual blood or saliva is present), are designed for multiple uses, provided they undergo proper cleaning and sterilization between patients.

Maintenance Features

Maintaining the Zest CHAIRSIDE® Denture Prep and Polish Kit involves strict adherence to cleaning and sterilization protocols to ensure patient safety and instrument longevity.

Immediate Post-Use Cleaning: Impurities must be removed from the instruments within two hours of use. This initial cleaning should be performed using running water or an FDA-approved and/or CE-marked disinfectant solution. The chosen disinfectant must be effective, suitable for dental instruments, and compatible with the materials of the kit.
Cleaning Bath Immersion: Instruments should be placed in a cleaning bath for the prescribed contact time and concentration, ensuring they do not contact each other to allow for thorough cleaning.
Ultrasonic Cleaning: For instruments with severe contamination, an ultrasonic bath is recommended to enhance cleaning effectiveness.
Bur Block Cleaning: The Bur Block, which holds the instruments, must be cleaned and disinfected separately without the instruments loaded. It is important to note that the Bur Block is not suitable for cleaning in a thermo disinfector (disinfector RDG).
Rinsing: After the cleaning bath, instruments must be rinsed for at least 3 minutes with tap water to remove any residual cleaning solution.
Drying: Excess moisture should be removed from all components using a clean, absorbent, and non-shedding wipe to prevent corrosion and ensure proper sterilization.
Inspection: Before sterilization, instruments must be checked for any damaged surfaces, chipped-off edges, or deformations. Any damaged instruments should be eliminated. Products that still show visible contaminants must be re-cleaned and disinfected until all contaminants are removed.
Packaging for Sterilization: Cleaned and disinfected instruments should be arranged in the dedicated bur block. The bur block, with instruments loaded, must then be wrapped using disposable sterilization packaging and/or placed in sterilization containers.
Sterilization Parameters: The assembled bur block and instruments must be sterilized according to specific parameters:
- Gravity Autoclave: 132°C for 25 minutes exposure time, followed by a 30-minute dry time.
- Pre-Vacuum Autoclave: 132°C for 4 minutes exposure time, followed by a 20-minute dry time.
Polisher Specifics: The Polisher is designated for single use if residual blood and/or saliva are present. This distinction is crucial for infection control.
Manufacturer's Instructions: Users are advised to refer to and strictly adhere to the manufacturers' instructions for use regarding the reaction time and suitability of disinfectants and detergents, as well as for any specific handling or storage requirements.
Storage: The kit, when in its undamaged, original packaging, does not require special considerations for storage or handling during transport and storage.
Disposal: Used devices that pose a risk of infection must be disposed of according to facility clinical waste procedures and applicable local and state regulations.