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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K222877
Device Name FREEPRINT crown
Applicant
DETAX GmbH
Carl-Zeiss-Strasse 4
Ettlingen,  DE D-76275
Applicant Contact Markus Stratmann
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBG  
Date Received09/22/2022
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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