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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K230341
Device Name ACRIFIX
Applicant
Deltamed GmbH
Raiffeisenstrasse 8a
Friedberg,  DE 61169
Applicant Contact Michael Zimmermann
Correspondent
Deltamed GmbH
Raiffeisenstrasse 8a
Friedberg,  DE 61169
Correspondent Contact Michael Zimmermann
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/08/2023
Decision Date 04/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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