LogoFDA 510(k) Search
K Number
K052189
Device Name
REVENEER CERAMIC REPAIR SYSTEM
Manufacturer
SCHUTZ-DENTAL GMBH
Date Cleared
2005-10-17

(67 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K974089,K943165,K973247,K043119
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:

  1. Primer
  2. Base
  3. Opaquer (light and dark)
  4. 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.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.