DENTURE CLEANSING TABLET— 510(k) K871785

Name: FDA 510(k) clearance K871785
Creator: U.S. Food and Drug Administration
Published: 1987-09-11

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.. Device class: 1.

Clearance details

Applicant: Pennex Products Co., Inc.
Product code: Code EFT
Device class: Class 1
Regulation: 21 CFR 872.3520
Advisory panel: Dental
Date received: 1987-05-06
Decision date: 1987-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Verona, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFT

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K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER2008-05-23
K051342 — MEDICAL INTERPOROUS2006-06-02
K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND2000-06-16
K942203 — OTC DENTURE CLEANSER1994-08-10
K930337 — PROFAST(R)-DENTURE CLEANSER1993-09-07

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.