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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 K200676
Device Name ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
Applicant
Zirkonzahn srl
Via An der Ahr 7
Gais,  IT 39030
Applicant Contact Julian Steger
Correspondent
Zirkonzahn srl
Via An der Ahr 7
Gais,  IT 39030
Correspondent Contact Sandra Leitner
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Codes
EBI   MQC  
Date Received03/16/2020
Decision Date 07/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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