Oral Surgery Contra— 510(k) K211584

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K211584 for Oral Surgery Contra, Substantially Equivalent on 2021-08-19. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code KMW
Advisory panel: Dental
Date received: 2021-05-24
Decision date: 2021-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanuma, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code KMW

product code KMW

Injury: 175
Total: 175

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.