IONODENT (TOOTHBRUSH)— 510(k) K874443

Name: FDA 510(k) clearance K874443
Creator: U.S. Food and Drug Administration
Published: 1988-07-19

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.. Device class: 1.

Clearance details

Applicant: U.S. Apatite Corp.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
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 ↗

Recent devices under product code EFW

view all

K130186 — DENTEK EASY BRUSH WITH FLUORIDE2013-07-15
K121165 — BEAM BRUSH/BEAM APP2012-06-21
K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH2011-10-03
K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH2008-02-06
K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL2002-07-17

More clearances from U.S. Apatite Corp.

view all

K883761 — IONODENT II (6 VOLTS)1988-12-05

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.