QUIK-BRUSH— 510(k) K870414

Substantially Equivalent

Intl. Medication Systems, Ltd.

FDA 510(k) clearance K870414 for QUIK-BRUSH, Substantially Equivalent on 1987-06-11. Applicant: Intl. Medication Systems, Ltd..

Clearance details

Applicant: Intl. Medication Systems, Ltd.
Product code: Code EFW
Advisory panel: Dental
Date received: 1987-02-03
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South El Monte, 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.