ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE— 510(k) K113222

Substantially Equivalent

Nakamura Dental Handpiece Mfg. Co., Ltd.

FDA 510(k) clearance K113222 for ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE, Substantially Equivalent on 2012-02-23. Applicant: Nakamura Dental Handpiece Mfg. Co., Ltd..

Clearance details

Applicant: Nakamura Dental Handpiece Mfg. Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2011-11-01
Decision date: 2012-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Itabashi-Ku, Tokyo, 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.