510(k) K173943— Dental High-speed Handpiece and Accessories

Substantially Equivalent

Microp Technology (Taiwan), Inc.

Clearance details

Applicant: Microp Technology (Taiwan), Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2017-12-26
Decision date: 2018-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiayi County, TW

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.