TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS

Powder, Porcelain

SCHUTZ-DENTAL GMBH

The following data is part of a premarket notification filed by Schutz-dental Gmbh with the FDA for Tizian Ceramic, Flow, Plate, Fix & Zr Blanks.

Pre-market Notification Details

Device IDK071010
510k NumberK071010
Device Name:TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
ClassificationPowder, Porcelain
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 CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-09
Decision Date2007-08-24
Summary:summary

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