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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
Recalls CDRH Recalls
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