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510(k) Data Aggregation
K Number
K110796Device Name
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
Manufacturer
BIOMERS PRODUCTS, LLC
Date Cleared
2011-03-31
(9 days)
Product Code
DYW, DZC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
BIOMERS PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An orthodontic archwire used to provide force to the teeth to effect movement in orthodontic treatment.
Device Description
The SimpliClear Rectangular Orthodontic Wire is a translucent archwire 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 the abrasion resistance properties of the wire.
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K Number
K101481Device Name
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
Manufacturer
BIOMERS PRODUCTS, LLC
Date Cleared
2010-06-23
(26 days)
Product Code
NJM, CLA
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
BIOMERS PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Device Description
The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
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