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510(k) Data Aggregation
K Number
K150830Device Name
CompleClear Plastic Orthodontic Bracket and Wire Appliance
Manufacturer
ORACREW
Date Cleared
2016-08-26
(515 days)
Product Code
DYW, DZC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
ORACREW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.
Device Description
CompleClear Plastic Orthodontic Bracket and Wire Appliance is an orthodontic appliance consisting of a polysulfone bracket with two separate components (tooth component and wire component) and an orthodontic wire pre-attached to the wire component of the bracket. The tooth and the wire components are capable of mechanically interlocking to form a detachable and reattachable bracket assembly. The tooth component of the bracket is cemented to the tooth, like regular orthodontic brackets. The wire components are pre-attached at specific positions along the orthodontic wire. The orthodontic wire is customized for each patient by creating various bends and rotations along the wire. This configuration of the customized wire, results in a specific position and orientation of the wire components of the bracket system along the customized wire. This customized orthodontic wire along with the series of pre-attached wire components constitutes the 'aligner'. When the wire components of the 'aligner' are engaged on to the corresponding tooth component cemented on the tooth, the orthodontic wire is activated like a spring. The tooth is gently moved to its desired position due to the elastic recoil of the wire.
The two component bracket assembly of the present device allows moment arms for mesiodistal rotation, labio-lingual inclination and mesio-distal angulations (tip) similar to conventional bracket-wire used in orthodontics.
The treatment uses a series of aligners, each incorporating a predefined amount to tooth movement toward the final desired end goal. The amount of tooth movement incorporated, the type of tooth movement incorporated and the final desired end goal are all determined and approved by the provider.
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