BruxZir Incisal Coloring Liquid User Manual

: June 16, 2024
: BruxZir

Table of Contents

Product Description
Indications for Use
Description of Label Symbols
Application Instructions
Sintering
Storage
Warning
Questions/Comments
Symbols Glossary
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BruxZir™ Incisal Coloring Liquid
Instructions for Use

Product Description

BruxZir™ Incisal Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C. BruxZir™ Incisal Coloring Liquid is available in 3 different colors: Premium, Premium HT, and Pearl. The devices are used on incisal areas of dental restoration to mimic natural tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.

Indications for Use

BruxZir™ Incisal Coloring Liquid is intended to be used by trained dental technicians as an accessory for shading BruxZir® Shaded 16 PLUS and BruxZir® Esthetic all zirconia, monolithic restorations for anterior and posterior dental prosthetics.

Description of Label Symbols

The title and symbol descriptions are in the symbols glossary on Page 2 of this document.

Application Instructions

**Caution:** Before applying BruxZir™ Incisal Coloring Liquid, follow the safety instructions in Section 7.
a) Restorations must be clean and dry before applying the product. Product will not work on wet or damp restorations.
b) Check the “Use by Date” on the label. Make sure the product has not expired.
c) Dispense only the amount of BruxZir™ Incisal Coloring Liquid needed for immediate use and make sure the bottle is tightly closed when not in use.
d) Use only a metal-free brush when applying BruxZir™ Incisal Coloring Liquid. Ensure the applicator is clean and free of any dust or debris.
e) Apply BruxZir™ Incisal Coloring Liquid to the restoration. Ensure the restoration surface is grease-free.
f) Air-dry the restoration or place it under a heat lamp. Make sure that the restoration is completely dry before sintering.

Sintering

Caution: Do not sinter wet or damp restorations.
Place the restoration in the sintering tray. Be careful that the restoration does not make contact with the sintering tray.
Note: For more information on the sintering and to complete the processing of the zirconia restoration, see the Instructions for Use for the specific restoration materials.

Storage

Store BruxZir™ Incisal Coloring Liquid at room temperature in the original packaging. Tightly cap after use.
Do not store in direct sunlight. Do not store near heat, flames, sparks, and ignition sources.
Caution: Do not use this product after the “Use by Date” listed on the product label.

Warning

Do not use the product without personal protective equipment (PPE) on. Always wear eye safety glasses/ goggles, protective apron/lab coat and chemical resistant gloves while using this product.
Contact with/inhalation of this product may cause eye damage/irritation, severe skin burns/ irritation or respiratory irritation.
Do not inhale fumes.
Use only in a well-ventilated area.
Store/keep BruxZir™ Incisal Coloring Liquid away from heat/sparks/open flames/hot surfaces.
BruxZir™ Incisal Coloring Liquid should be used only as indicated. Read instructions before use.

Note: To request the SDS for this product, call Glidewell Direct at 888-303-3975.

Questions/Comments

For questions and/or comments or for further instructions regarding the use of this product, please contact Glidewell Direct at 18651 Von Karman Ave., Irvine, CA 92612, USA or by calling 888-303-3975.

Symbols Glossary

Symbol| Reference No. 21 CFR Part 801, Section| Title — Symbol Description
---|---|---
| 801.109(b)(1)| By Prescription Only — Caution: Federal law restricts this device to sale by or on the order of a dentist or physician.
Symbol| Reference No. EN ISO 15223-1, Section| Title — Symbol Description
| 5.1.1| Manufacturer — Indicates the medical device manufacturer.
**| 5.1.3| Date of Manufacture — Indicates the date (YYYYMM-DD) when the medical device was manufactured.
| 5.1.4| Use by Date — Indicates the date (YYYY-MM-DD)
after which the medical device is not to be used.
| 5.1.5| Lot Number— Indicates the manufacturer’s batch code so that the lot can be identified.
| 5.1.6| Catalogue Number — Indicates the manufacturer’s catalogue number so that the medical device can be identified.
| 5.2.7| Non-Sterile — Indicates a medical device that has not been subjected to a sterilization process.
| 5.3.2| Keep Away from Sunlight — Indicates a medical device that needs protection from light sources.
| 5.3.7| Upper Limit of Temperature — Indicates the upper limit of temperature to which the medical device can be safely exposed.
| 5.4.3| Consult Instructions for Use — Indicates the need for the user to consult the instruction for use.
| 5.4.4| Caution — Indicates the user needs to consult the instructions for use for important cautionary information such as warnings and precautions.
Symbol| Reference No. 29 CFR 1910.1200 – Appendix C, Section| Title — Symbol Description**
| C.2.3.2 Figure C.1— Hazard Symbols and Classes| Irritant — Indicates product contact/inhalation will irritate eyes, skin, respiratory tract.
| C.2.3.2, 2 Figure C.1— Hazard Symbols and Classes| Corrosive — Indicates product contact causes serious eye damage, severe burns and is corrosive to metals.