RIGIDENT CREAM— 510(k) K854430

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K854430 for RIGIDENT CREAM, Substantially Equivalent on 1986-03-04. Applicant: Armkel, LLC.

Clearance details

Applicant: Armkel, LLC
Product code: Code KOT
Advisory panel: Dental
Date received: 1985-11-05
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOT

product code KOT

Death: 5
Injury: 309
Total: 314

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.