IONODENT (TOOTHBRUSH)— 510(k) K874443

Substantially Equivalent

U.S. Apatite Corp.

FDA 510(k) clearance K874443 for IONODENT (TOOTHBRUSH), Substantially Equivalent on 1988-07-19. Applicant: U.S. Apatite Corp..

Clearance details

Applicant: U.S. Apatite Corp.
Product code: Code EFW
Advisory panel: Dental
Date received: 1987-10-28
Decision date: 1988-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.