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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 K212509
Device Name OSSIX Breeze
Applicant
Datum Dental Ltd.
1 Bat Sheva St., PO Box 6170
Lod,  IL 7116003
Applicant Contact Arie Goldlust
Correspondent
Hogan Lovells US LPP
1735 Market Street
Floor 23
Philladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number872.3930
Classification Product Code
NPL  
Date Received08/09/2021
Decision Date 07/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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