SIC Abutments including CAD/CAM Solutions— 510(k) K252904

Name: FDA 510(k) clearance K252904
Creator: U.S. Food and Drug Administration
Published: 2026-06-03

Substantially Equivalent

Sic Invent AG

FDA 510(k) clearance K252904 for SIC Abutments including CAD/CAM Solutions, Substantially Equivalent on 2026-06-03. Applicant: Sic Invent AG. Device class: 2.

Clearance details

Applicant: Sic Invent AG
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2025-09-11
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

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More clearances from Sic Invent AG

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K210489 — SICtapered & SICvantage tapered2022-03-17
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K061500 — SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS2006-08-08
K040757 — SIC PRO2005-04-13

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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