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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 K160281
Device Name OSSIX PLUS
Applicant
Datum Dental Ltd.
1 Bat Sheva St., PO Box 6170
Lod,  IL 7116003
Applicant Contact Arie Goldlust
Correspondent
Hogan Lovells US LLP
1835 Market Street, 29th Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number872.3930
Classification Product Code
NPL  
Date Received02/02/2016
Decision Date 08/04/2016
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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