DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS

Band, Elastic, Orthodontic

DENTAURAUM, INC.

The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Olympia Latex-elastics And Dentaurum Latex-elastics.

Pre-market Notification Details

Device IDK935144
510k NumberK935144
Device Name:DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
ClassificationBand, Elastic, Orthodontic
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 CodeECI  
CFR Regulation Number872.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-28
Decision Date1994-02-04

NIH GUDID Devices

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