Cleared Traditional

K943486 - ORAFIX SPECIAL DENTURE ADHESIVE

K943486 is an FDA 510(k) clearance for ORAFIX SPECIAL DENTURE ADHESIVE, manufactured by Smithkline Beecham Corp.. The device is a Class 1 Dental device with product code KOO cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K943486 · Smithkline Beecham Corp. · Dental device
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Nov 1994
Decision
107d
Days
Class 1
Risk

K943486 is an FDA 510(k) clearance for the ORAFIX SPECIAL DENTURE ADHESIVE. Classified as Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt (product code KOO), Class I - General Controls.

Submitted by Smithkline Beecham Corp. (Parsippany, US). The FDA issued a Cleared decision on November 3, 1994 after a review of 107 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 Smithkline Beecham Corp. devices

FDA 510(k) Submission Details - K943486

510(k) Number K943486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1994
Decision Date November 03, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

KOO Device Classification - Class 1, General Controls

Product Code KOO Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt
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.