Zenostar MT, Zenostar Color Liquids

Powder, Porcelain

WIELAND DENTAL + TECHNIK GMBH & CO. KG

The following data is part of a premarket notification filed by Wieland Dental + Technik Gmbh & Co. Kg with the FDA for Zenostar Mt, Zenostar Color Liquids.

Pre-market Notification Details

Device IDK152118
510k NumberK152118
Device Name:Zenostar MT, Zenostar Color Liquids
ClassificationPowder, Porcelain
Applicant WIELAND DENTAL + TECHNIK GMBH & CO. KG LINDERSTRASSE 2 Pfozheim,  DE 75179
ContactBetina Kistner
CorrespondentDonna Marie Hartnett
IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE Amherst,  NY  14228
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-30
Decision Date2015-12-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.