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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K250739
Device Name Primeprint Direct Aligner
Applicant
Dreve Dentamid GmbH
Max-Planck-Str. 31
Unna,  DE 59423
Applicant Contact Anke Hüttenbrauck
Correspondent
Dreve Dentamid GmbH
Max-Planck-Str. 31
Unna,  DE 59423
Correspondent Contact Anke Hüttenbrauck
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/11/2025
Decision Date 11/07/2025
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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