Dental Handpiece, Model CA160, CA160L, and CA500L— 510(k) K220577

Substantially Equivalent

Micro-Nx Co., Ltd.

FDA 510(k) clearance K220577 for Dental Handpiece, Model CA160, CA160L, and CA500L, Substantially Equivalent on 2022-07-29. Applicant: Micro-Nx Co., Ltd..

Clearance details

Applicant: Micro-Nx Co., Ltd.
Product code: Code EGS
Advisory panel: Dental
Date received: 2022-02-28
Decision date: 2022-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dong-Gu, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.