REMANIUM: 200,CS, 380, AND CD

Alloy, Metal, Base

DENTAURAUM, INC.

The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Remanium: 200,cs, 380, And Cd.

Pre-market Notification Details

Device IDK952865
510k NumberK952865
Device Name:REMANIUM: 200,CS, 380, AND CD
ClassificationAlloy, Metal, Base
Applicant DENTAURAUM, INC. 10 PHEASANT RUN Newtown,  PA  18940
ContactJohn J Roth, Jr.
CorrespondentJohn J Roth, Jr.
DENTAURAUM, INC. 10 PHEASANT RUN Newtown,  PA  18940
Product CodeEJH  
CFR Regulation Number872.3710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-22
Decision Date1995-07-26

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