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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K220823
Device Name Preat Abutments
Applicant
Preat Corporation
2625 Skyway Dr, Suite B
Santa Maria,  CA  93455
Applicant Contact Chris Bormes
Correspondent
Aclivi, LLC
3250 Brackley Drive
Ann Arbor,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/21/2022
Decision Date 10/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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