GenesisZr UHT700 Zirconia

Powder, Porcelain

United Dental Resources Corporation

The following data is part of a premarket notification filed by United Dental Resources Corporation with the FDA for Genesiszr Uht700 Zirconia.

Pre-market Notification Details

Device IDK201608
510k NumberK201608
Device Name:GenesisZr UHT700 Zirconia
ClassificationPowder, Porcelain
Applicant United Dental Resources Corporation 70 Towncenter Drive University Park,  IL  60417
ContactJohn Von Thaden
CorrespondentJohn Von Thaden
United Dental Resources Corporation 70 Towncenter Drive University Park,  IL  60417
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2021-01-28

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