Cleared Traditional

ZAFIRA?

K254245 · New Stetic, SA · Dental

Mar 2026

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K254245 is an FDA 510(k) clearance for the ZAFIRA?, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by New Stetic, SA (Guarne, CO). The FDA issued a Cleared decision on March 3, 2026, 64 days after receiving the submission on December 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K254245 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2025
Decision Date	March 03, 2026
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF