PRETTAU ANTERIOR T0

Powder, Porcelain

ZIRKONZAHN GMBH

The following data is part of a premarket notification filed by Zirkonzahn Gmbh with the FDA for Prettau Anterior T0.

Pre-market Notification Details

Device IDK151490
510k NumberK151490
Device Name:PRETTAU ANTERIOR T0
ClassificationPowder, Porcelain
Applicant ZIRKONZAHN GMBH GEWERBEGEBIET - ZONA INDUSTRIALE AN DER AHR 7 Gais (bz),  IT 39030
ContactHeinrich Steger
CorrespondentEnrico Bisson
TUV RHEINLAND ITALIA S.R.L. VIA DELLA SALUTE 18/3 Bologna,  IT 40132
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-03
Decision Date2015-10-08
Summary:summary

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