ZAFIRA®— 510(k) K254245

Substantially Equivalent

New Stetic, SA

FDA 510(k) clearance K254245 for ZAFIRA®, Substantially Equivalent on 2026-03-03. Applicant: New Stetic, SA.

Clearance details

Applicant: New Stetic, SA
Product code: Code EBF
Advisory panel: Dental
Date received: 2025-12-29
Decision date: 2026-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guarne, CO

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Data sourced from openFDA. This site is unofficial and independent of the FDA.