RIGIDENT CREAM— 510(k) K854430

Name: FDA 510(k) clearance K854430
Creator: U.S. Food and Drug Administration
Published: 1986-03-04

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K854430 for RIGIDENT CREAM, Substantially Equivalent on 1986-03-04. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code KOT
Device class: Class 1
Regulation: 21 CFR 872.3490
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 ↗

Recent devices under product code KOT

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K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM1994-12-20
K941365 — MPI DENTURE ADHESIVE FILM SEALS1994-04-22
K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM1990-10-24
K895818 — STEADFAST DENTURE ADHESIVE CREAM1990-04-03
K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM1988-11-01

More clearances from Armkel, LLC

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K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST2004-10-19
K030258 — FIRST RESPONSE PREGNANCY TEST2003-02-25
K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS2002-12-16
K013433 — TROJAN PASSION BERRY GEL2002-03-05
K013614 — TROJAN CRYSTAL CLEAR LIQUID2002-02-01

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.