510(k) K141221— LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR

Substantially Equivalent

Lares Research, Inc.

Clearance details

Applicant: Lares Research, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2014-05-12
Decision date: 2014-10-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chico, CA, US

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.