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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K190571
Device Name StoneBite and StoneBite scan
Applicant
Dreve Dentamid GmbH
Max-Planck-Strasse 31
Unna,  DE 59423
Applicant Contact Reiner Altmann
Correspondent
Bqc Consulting, LLC
24341 Barbados Dr.
Dana Point,  CA  92629
Correspondent Contact Nevine Erian
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/06/2019
Decision Date 11/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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