Ortholock Anchorage Devices

Implant, Endosseous, Orthodontic

Craniofacial Technologies, Inc.

The following data is part of a premarket notification filed by Craniofacial Technologies, Inc. with the FDA for Ortholock Anchorage Devices.

Pre-market Notification Details

Device IDK202691
510k NumberK202691
Device Name:Ortholock Anchorage Devices
ClassificationImplant, Endosseous, Orthodontic
Applicant Craniofacial Technologies, Inc. 98 Buckskin Road West Hills,  CA  91307
ContactKevin Kaveh
CorrespondentMichael Nilo
Nilo Medical Consulting Group 3419 Denny Street Pittsburgh,  PA  15201
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-15
Decision Date2022-04-28

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