ABRO 1, RESITON GINGIVA, PRIME And THERAPON TRANSPA

Crown And Bridge, Temporary, Resin

Zirkonzahn Srl

The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Abro 1, Resiton Gingiva, Prime And Therapon Transpa.

Pre-market Notification Details

Device IDK200676
510k NumberK200676
Device Name:ABRO 1, RESITON GINGIVA, PRIME And THERAPON TRANSPA
ClassificationCrown And Bridge, Temporary, Resin
Applicant Zirkonzahn Srl Via An Der Ahr 7 Gais,  IT 39030
ContactJulian Steger
CorrespondentSandra Leitner
Zirkonzahn Srl Via An Der Ahr 7 Gais,  IT 39030
Product CodeEBG  
Subsequent Product CodeEBI
Subsequent Product CodeMQC
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2020-07-08

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