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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 K254245
Device Name ZAFIRA®
Applicant
New Stetic, SA
Carrera 53, # 50-09
Guarne,  CO
Applicant Contact Juan David Jaramillo Gomez
Correspondent
Aclivi, LLC
405 Tropics Ave.
Daytona Beach,  FL  32124
Correspondent Contact Chris Brown
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/29/2025
Decision Date 03/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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