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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 K253312
Device Name OrangeCAD Med Abutments
Applicant
Orangecad Med GmbH
Emmy-Noether-Strasse 11
Karlsruhe,  DE 76131
Applicant Contact Markus Munz
Correspondent
Aclivi, LLC
3250 Brackley Dr.
Ann Abror,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/30/2025
Decision Date 12/23/2025
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
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