DENTAURUM STEEL LIGATURE WIRES

Wire, Orthodontic

DENTAURAUM, INC.

The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Dentaurum Steel Ligature Wires.

Pre-market Notification Details

Device IDK935140
510k NumberK935140
Device Name:DENTAURUM STEEL LIGATURE WIRES
ClassificationWire, 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 CodeDZC  
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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