DENTURE CLEANSING TABLET— 510(k) K871785

Substantially Equivalent

Pennex Products Co., Inc.

FDA 510(k) clearance K871785 for DENTURE CLEANSING TABLET, Substantially Equivalent on 1987-09-11. Applicant: Pennex Products Co., Inc..

Clearance details

Applicant: Pennex Products Co., Inc.
Product code: Code EFT
Advisory panel: Dental
Date received: 1987-05-06
Decision date: 1987-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Verona, PA, 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.