BIOPORTA SOLDER 1020

Alloy, Gold-based Noble Metal

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 Bioporta Solder 1020.

Pre-market Notification Details

Device IDK022462
510k NumberK022462
Device Name:BIOPORTA SOLDER 1020
ClassificationAlloy, Gold-based Noble Metal
Applicant WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRASSE 13 Pforzheim,  DE D 75179
ContactGerhard Polzer
CorrespondentGerhard Polzer
WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRASSE 13 Pforzheim,  DE D 75179
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-26
Decision Date2002-09-18
Summary:summary

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