Cleared Traditional

K910216 - STEADFAST DENTURE ADHESIVE POWDER (FDA 510(k) Clearance)

Class I Dental device.

K910216 · Stiefel Research Institute, Inc. · Dental device
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Mar 1991
Decision
71d
Days
Class 1
Risk

K910216 is an FDA 510(k) clearance for the STEADFAST DENTURE ADHESIVE POWDER. Classified as Adhesive, Denture, Acacia And Karaya With Sodium Borate (product code KOM), Class I - General Controls.

Submitted by Stiefel Research Institute, Inc. (Oakhill, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stiefel Research Institute, Inc. devices

Submission Details

510(k) Number K910216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1991
Decision Date March 29, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOM Adhesive, Denture, Acacia And Karaya With Sodium Borate
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3400
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.