PROPHYflex 4— 510(k) K181110

Substantially Equivalent

Kaltenbach & Voigt GmbH

FDA 510(k) clearance K181110 for PROPHYflex 4, Substantially Equivalent on 2019-04-10. Applicant: Kaltenbach & Voigt GmbH.

Clearance details

Applicant: Kaltenbach & Voigt GmbH
Product code: Code EFB
Advisory panel: Dental
Date received: 2018-04-27
Decision date: 2019-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Biberach, DE

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.