PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M— 510(k) K101551

Substantially Equivalent

Delma Medical Instrument (Guangzhou) Co., Ltd.

FDA 510(k) clearance K101551 for PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M, Substantially Equivalent on 2010-09-09. Applicant: Delma Medical Instrument (Guangzhou) Co., Ltd..

Clearance details

Applicant: Delma Medical Instrument (Guangzhou) Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2010-06-04
Decision date: 2010-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

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.