Maxima PRO 45L— 510(k) K141576

Substantially Equivalent

Kavo DO Brasil Industria E Comercio Ltda

FDA 510(k) clearance K141576 for Maxima PRO 45L, Substantially Equivalent on 2015-05-04. Applicant: Kavo DO Brasil Industria E Comercio Ltda.

Clearance details

Applicant: Kavo DO Brasil Industria E Comercio Ltda
Product code: Code EFB
Advisory panel: Dental
Date received: 2014-06-12
Decision date: 2015-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Catarina, BR

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.