OTC DENTURE CLEANSER— 510(k) K942203

Substantially Equivalent

Combe, Inc.

FDA 510(k) clearance K942203 for OTC DENTURE CLEANSER, Substantially Equivalent on 1994-08-10. Applicant: Combe, Inc..

Clearance details

Applicant: Combe, Inc.
Product code: Code EFT
Advisory panel: Dental
Date received: 1994-05-05
Decision date: 1994-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

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Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.