PRE-MILLED Abutment— 510(k) K202269

Substantially Equivalent

Mit Global Co., Ltd.

FDA 510(k) clearance K202269 for PRE-MILLED Abutment, Substantially Equivalent on 2020-11-25. Applicant: Mit Global Co., Ltd..

Clearance details

Applicant: Mit Global Co., Ltd.
Product code: Code NHA
Advisory panel: Dental
Date received: 2020-08-11
Decision date: 2020-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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.