General Cutting Contra Handpiece— 510(k) K182999

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K182999 for General Cutting Contra Handpiece, Substantially Equivalent on 2019-04-16. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code EGS
Advisory panel: Dental
Date received: 2018-10-30
Decision date: 2019-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanuma-Shi, JP

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.