Cleared Traditional

K895818 - STEADFAST DENTURE ADHESIVE CREAM (FDA 510(k) Clearance)

Class I Dental device.

K895818 · Stiefel Research Institute, Inc. · Dental device
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Apr 1990
Decision
186d
Days
Class 1
Risk

K895818 is an FDA 510(k) clearance for the STEADFAST DENTURE ADHESIVE CREAM. Classified as Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium (product code KOT), Class I - General Controls.

Submitted by Stiefel Research Institute, Inc. (Oakhill, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 186 days - an extended review cycle.

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 Stiefel Research Institute, Inc. devices

Submission Details

510(k) Number K895818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1989
Decision Date April 03, 1990
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
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.