ORALCHEK SUPER-SOFT BRUSH— 510(k) K892264

Substantially Equivalent

Pfizer, Inc.

FDA 510(k) clearance K892264 for ORALCHEK SUPER-SOFT BRUSH, Substantially Equivalent on 1989-06-14. Applicant: Pfizer, Inc..

Clearance details

Applicant: Pfizer, Inc.
Product code: Code EFW
Advisory panel: Dental
Date received: 1989-04-05
Decision date: 1989-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ny, NY, 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.