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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 K241226
Device Name Fixtemp® C&B 4:1
Applicant
Dreve Denatmid GmbH
Max-Planck-Strasse 31
59423 Unna
Nordrhein-Westfalen,  DE
Applicant Contact Anke Hüttenbrauck
Correspondent
Bqc Consulting, LLC
24341 Barbados Dr.
Dana Point,  CA  92629
Correspondent Contact Nevine Erian
Regulation Number872.3770
Classification Product Code
EBG  
Date Received05/02/2024
Decision Date 05/31/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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