BIOMERS TRANSLUCENT ORTHODONTIC WIRE

Bracket, Plastic, Orthodontic

BIOMERS PRODUCT, LLC

The following data is part of a premarket notification filed by Biomers Product, Llc with the FDA for Biomers Translucent Orthodontic Wire.

Pre-market Notification Details

Device IDK081143
510k NumberK081143
Device Name:BIOMERS TRANSLUCENT ORTHODONTIC WIRE
ClassificationBracket, Plastic, Orthodontic
Applicant BIOMERS PRODUCT, LLC 2316 PINE RIDGE ROAD SUITE 459 Naples,  FL  34109
ContactGeorge Aliphtiras
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeDYW  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-04-22
Decision Date2008-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J011766906000 K081143 000

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