S.I.N. Dental Implant System— 510(k) K252266

Name: FDA 510(k) clearance K252266
Creator: U.S. Food and Drug Administration
Published: 2025-10-17

Substantially Equivalent

S.I.N. Implant System Ltda

FDA 510(k) clearance K252266 for S.I.N. Dental Implant System, Substantially Equivalent on 2025-10-17. Applicant: S.I.N. Implant System Ltda. Device class: 2.

Clearance details

Applicant: S.I.N. Implant System Ltda
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2025-07-21
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Paulo, BR

Download summary PDF View on FDA.gov ↗

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More clearances from S.I.N. Implant System Ltda

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K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System2025-11-07
K251262 — S.I.N. Dental Implant System2025-09-26
K251046 — S.I.N. Dental Implant System2025-08-13

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.