IONODENT II (6 VOLTS)— 510(k) K883761

Substantially Equivalent

U.S. Apatite Corp.

FDA 510(k) clearance K883761 for IONODENT II (6 VOLTS), Substantially Equivalent on 1988-12-05. Applicant: U.S. Apatite Corp..

Clearance details

Applicant: U.S. Apatite Corp.
Product code: Code EFW
Advisory panel: Dental
Date received: 1988-09-06
Decision date: 1988-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canoga Park, CA, US

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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.