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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Animal Source
510(k) Number K163714
FOIA Releasable 510(k) K163714
Device Name OSSIX BONE
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 ST, 29TH FL
PHILADELPHIA,  PA  19103
Correspondent Contact Janice M Hogan
Regulation Number872.3930
Classification Product Code
NPM  
Date Received12/30/2016
Decision Date 07/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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