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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
Dreve Dentamid GmbH
Max-Planck-Strasse 31
unna,  DE 59423
Applicant Contact reiner altmann
BQC Consulting LLC
24341 Barbados Dr.
dana point,  CA  92629
Correspondent Contact nevine erian
Regulation Number872.3660
Classification Product Code
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