METAL-LINED TRANSCEND CERAMIC BRACKET

Bracket, Plastic, Orthodontic

UNITEK CORP.

The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Metal-lined Transcend Ceramic Bracket.

Pre-market Notification Details

Device IDK944286
510k NumberK944286
Device Name:METAL-LINED TRANSCEND CERAMIC BRACKET
ClassificationBracket, Plastic, Orthodontic
Applicant UNITEK CORP. 2724 SOUTH PECK RD. Monrovia,  CA  91016 -5097
ContactMarlyn Scheff
CorrespondentMarlyn Scheff
UNITEK CORP. 2724 SOUTH PECK RD. Monrovia,  CA  91016 -5097
Product CodeDYW  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-02
Decision Date1994-11-29

NIH GUDID Devices

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