REVENEER CERAMIC REPAIR SYSTEM

Agent, Tooth Bonding, Resin

SCHUTZ-DENTAL GMBH

The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Reveneer Ceramic Repair System.

Pre-market Notification Details

Device IDK052189
510k NumberK052189
Device Name:REVENEER CERAMIC REPAIR SYSTEM
ClassificationAgent, Tooth Bonding, Resin
Applicant SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen,  DE D-61191
ContactMichael Wierz
CorrespondentMichael Wierz
SCHUTZ-DENTAL GMBH DIESELSTRASSE 5-6 Rosbach, Hessen,  DE D-61191
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-11
Decision Date2005-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EBIB741401 K052189 000
EBIB740101 K052189 000
EBIB740201 K052189 000
EBIB740301 K052189 000
EBIB740401 K052189 000
EBIB740501 K052189 000
EBIB740801 K052189 000
EBIB740901 K052189 000
EBIB741001 K052189 000
EBIB741101 K052189 000
EBIB740001 K052189 000

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