Cleared Traditional

K895818 - STEADFAST DENTURE ADHESIVE CREAM

K895818 is an FDA 510(k) clearance for STEADFAST DENTURE ADHESIVE CREAM, manufactured by Stiefel Research Institute, Inc.. The device is a Class 1 Dental device with product code KOT cleared through the Traditional 510(k) pathway after a 186-day FDA review.

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

FDA 510(k) Submission Details - K895818

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.

KOT Device Classification - Class 1, General Controls

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.