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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, orthodontic
510(k) Number K202691
Device Name Ortholock Anchorage Devices
Applicant
Craniofacial Technologies, Inc.
98 Buckskin Road
West Hills,  CA  91307
Applicant Contact Kevin Kaveh
Correspondent
Nilo Medical Consulting Group
3419 Denny Street
Pittsburgh,  PA  15201
Correspondent Contact Michael Nilo
Regulation Number872.3640
Classification Product Code
OAT  
Date Received09/15/2020
Decision Date 04/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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