PROFAST(R)-DENTURE CLEANSER— 510(k) K930337

Substantially Equivalent

Fittydent-Altwirth & Schmitt GmbH

FDA 510(k) clearance K930337 for PROFAST(R)-DENTURE CLEANSER, Substantially Equivalent on 1993-09-07. Applicant: Fittydent-Altwirth & Schmitt GmbH.

Clearance details

Applicant: Fittydent-Altwirth & Schmitt GmbH
Product code: Code EFT
Advisory panel: Dental
Date received: 1993-01-22
Decision date: 1993-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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.