Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)— 510(k) K241880

Substantially Equivalent

Nakanishi, Inc.

FDA 510(k) clearance K241880 for Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip), Substantially Equivalent on 2024-09-20. Applicant: Nakanishi, Inc..

Clearance details

Applicant: Nakanishi, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2024-06-28
Decision date: 2024-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanuma, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.