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510(k) Data Aggregation
K Number
K202691Device Name
Ortholock Anchorage Devices
Manufacturer
Craniofacial Technologies, Inc.
Date Cleared
2022-04-28
(590 days)
Product Code
OAT
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Craniofacial Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortholock Anchorage Devices are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
Device Description
The Ortholock anchorage device is an implantable self-drilling orthodontic microimplant intended to provide a temporary fixed anchorage point to facilitate orthodontic treatment. The device interacts with an appliance accessory, which includes two insertion locations for Ortholock and a tube for the attachment of general orthodontic appliances. The devices are made from Ti6Al4V and their surfaces are anodized so the different lengths can easily be visually identified.
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