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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K171729
Device Name Fixtemp C&B
Applicant
Dreve Dentamid GmbH
Max-Planck-Strabe 31
Unna,  DE 59423
Applicant Contact Reiner Altmann
Correspondent
Dreve Dentamid GmbH
Max-Planck-Strabe 31
Unna,  DE 59423
Correspondent Contact Reiner Altmann
Regulation Number872.3770
Classification Product Code
EBG  
Date Received06/12/2017
Decision Date 12/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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