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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K241579
Device Name DD Hybridlayer (multicolored zirconia)
Applicant
Dental Direkt GmbH
Industriezentrum 106-108
Spenge,  DE 32139
Applicant Contact Patrick Berz
Correspondent
Dental Direkt GmbH
Industriezentrum 106-108
Spenge,  DE 32139
Correspondent Contact Patrick Berz
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/03/2024
Decision Date 09/06/2024
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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