PORTADUR P2

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 Portadur P2.

Pre-market Notification Details

Device IDK023395
510k NumberK023395
Device Name:PORTADUR P2
ClassificationAlloy, Gold-based Noble Metal
Applicant WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim,  DE D-75179
ContactGerhard Polzer
CorrespondentGerhard Polzer
WIELAND DENTAL + TECHNIK GMBH & CO. KG SCHWENNINGER STRABE 13 Pforzheim,  DE D-75179
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-09
Decision Date2002-12-11
Summary:summary

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