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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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