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510(k) Data Aggregation
K Number
K081143Device Name
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
Manufacturer
BIOMERS PRODUCT, LLC
Date Cleared
2008-05-02
(10 days)
Product Code
DYW, DZC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
BIOMERS PRODUCT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.
Device Description
The BioMers Translucent Orthodontic Wire is a translucent arch wire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases theabrasion resistance properties of the wire.
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