Cleared Traditional

RIGIDENT CREAM (K854430) - FDA 510(k) Clearance

Class I Dental device.

K854430 · Armkel, LLC · Dental device
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Mar 1986
Decision
119d
Days
Class 1
Risk

K854430 is an FDA 510(k) clearance for the RIGIDENT CREAM. Classified as Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium (product code KOT), Class I - General Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3490 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Armkel, LLC devices

Submission Details

510(k) Number K854430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date March 04, 1986
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOT Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3490
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.