VITA Ambria

Powder, Porcelain

VITA Zahnfabrik GmbH H Rauter & Co

The following data is part of a premarket notification filed by Vita Zahnfabrik Gmbh H Rauter & Co with the FDA for Vita Ambria.

Pre-market Notification Details

Device IDK193436
510k NumberK193436
Device Name:VITA Ambria
ClassificationPowder, Porcelain
Applicant VITA Zahnfabrik GmbH H Rauter & Co Spitelgasse 3 Bad Sackingen,  DE D-79713
ContactBernd Walker
CorrespondentLindsay Tilton
VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda,  CA  92887
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-11
Decision Date2020-05-14

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