BIO PONTOSTAR

Alloy, Gold-based Noble Metal

BEGO U.S.A.

The following data is part of a premarket notification filed by Bego U.s.a. with the FDA for Bio Pontostar.

Pre-market Notification Details

Device IDK983077
510k NumberK983077
Device Name:BIO PONTOSTAR
ClassificationAlloy, Gold-based Noble Metal
Applicant BEGO U.S.A. 1088 MAIN ST. SUITE 200 Pawtucket,  RI  02860
ContactWilliam Oremus
CorrespondentWilliam Oremus
BEGO U.S.A. 1088 MAIN ST. SUITE 200 Pawtucket,  RI  02860
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-02
Decision Date1998-10-23

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