REMANIUM:GM 700, GM 380, GM 800, GFH

Alloy, Metal, Base

DENTAURAUM, INC.

The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Remanium:gm 700, Gm 380, Gm 800, Gfh.

Pre-market Notification Details

Device IDK952867
510k NumberK952867
Device Name:REMANIUM:GM 700, GM 380, GM 800, GFH
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 Date1995-07-27

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