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510(k) Data Aggregation
K Number
K050408Device Name
BICON ORTHODONTIC IMPLANT SYSTEMManufacturer
Date Cleared
2005-04-07
(49 days)
Product Code
Regulation Number
872.3640Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Bicon Orthodontic Implant System is intended for those cases where a clinician desires to provide a fixed point of anchorage to which orthodontic appliances may be attached to orthodontically move teeth. The system consists of a small implant that is screwed into the jawbone that will be removed after completion of treatment.
Device Description
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AI/ML Overview
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