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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K262415
Device Name OSSIX Plus
Applicant
Datum Dental, Ltd.
38 Hayarkon St.
Yavne Centra,  IL 28277
Applicant Contact Thomas Bayer
Correspondent
Hogan Lovells US Llp
1735 Market St., Floor 23
Philadelphia,  PA  19103
Correspondent Contact Kelliann Payne
Regulation Number872.3930
Classification Product Code
NPL  
Date Received07/15/2026
Decision Date 10/29/2026
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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