SIMDA Abutments— 510(k) K252320

Name: FDA 510(k) clearance K252320
Creator: U.S. Food and Drug Administration
Published: 2025-12-18

Substantially Equivalent

Simda Co., Ltd.

FDA 510(k) clearance K252320 for SIMDA Abutments, Substantially Equivalent on 2025-12-18. Applicant: Simda Co., Ltd.. Device class: 2.

Clearance details

Applicant: Simda Co., Ltd.
Product code: Product code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2025-07-25
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Simda Co., Ltd.

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K232271 — SIMDA abutment2023-10-26
K223663 — SIMDA Abutment2023-05-24

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.