INCORIS TZI

Powder, Porcelain

SIRONA DENTAL SYSTEMS GMBH

The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Incoris Tzi.

Pre-market Notification Details

Device IDK123545
510k NumberK123545
Device Name:INCORIS TZI
ClassificationPowder, Porcelain
Applicant SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim,  DE D-64625
ContactFritz Kolle
CorrespondentFritz Kolle
SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim,  DE D-64625
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-19
Decision Date2013-02-01
Summary:summary

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