OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment— 510(k) K242366

Name: FDA 510(k) clearance K242366
Creator: U.S. Food and Drug Administration
Published: 2025-01-10

Substantially Equivalent

Overfibers S.R.L.

FDA 510(k) clearance K242366 for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment, Substantially Equivalent on 2025-01-10. Applicant: Overfibers S.R.L.. Device class: 2.

Clearance details

Applicant: Overfibers S.R.L.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2024-08-09
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola (Bo), IT

Download summary PDF View on FDA.gov ↗

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