ZACT DENTAL ARCH TOOTHBRUSCH— 510(k) K833815

Substantially Equivalent

Jfc International, Inc.

FDA 510(k) clearance K833815 for ZACT DENTAL ARCH TOOTHBRUSCH, Substantially Equivalent on 1984-02-10. Applicant: Jfc International, Inc..

Clearance details

Applicant: Jfc International, Inc.
Product code: Code EFW
Advisory panel: Dental
Date received: 1983-11-02
Decision date: 1984-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.