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510(k) Data Aggregation

K Number

Device Name

REVENEER CERAMIC REPAIR SYSTEM

Manufacturer

SCHUTZ-DENTAL GMBH

Date Cleared

2005-10-17

(67 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K974089,K943165,K973247,K043119

Why did this record match?

Device Name :

REVENEER CERAMIC REPAIR SYSTEM

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages:

no acid etching (neither hydrofluoric nor phosphoric acid)
safe intraoral use
extremely good bond strength
time saving
can be used universally, with all conventional ceramics
use of conventional curing lights (halogen, LED, plasma)

Device Description

ReVeneer Ceramic Repair System with the following components:

Primer
Base
Opaquer (light and dark)
Composite Fillis

AI/ML Overview

The requested information is not available in the provided text. The document is a 510(k) summary for a "ReVeneer Ceramic Repair System" and contains administrative and regulatory information, but no details about acceptance criteria or a study proving device performance are present.

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