DENTAL HANDPIECE— 510(k) K093971

Substantially Equivalent

North West Medical Instrument (Group) Co., Ltd.

FDA 510(k) clearance K093971 for DENTAL HANDPIECE, Substantially Equivalent on 2010-04-22. Applicant: North West Medical Instrument (Group) Co., Ltd..

Clearance details

Applicant: North West Medical Instrument (Group) Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2009-12-24
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.