Not Cleared Post-NSE

DEN050001 - DECAPINOL ORAL RINSE

DEN050001 is an FDA 510(k) submission for DECAPINOL ORAL RINSE, manufactured by Sinclair Pharmaceuticals Limited. The device is a Class 2 Dental device with product code NTO cleared through the Post-NSE 510(k) pathway after a 84-day FDA review.

DEN050001 · Sinclair Pharmaceuticals Limited · Dental device
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Apr 2005
Decision
84d
Days
Class 2
Risk

DEN050001 is an FDA 510(k) submission (not cleared) for the DECAPINOL ORAL RINSE. Classified as Rinse, Oral, Antibacterial (by Physical Means) (product code NTO), Class II - Special Controls.

Submitted by Sinclair Pharmaceuticals Limited (Godalming, Surrey, GB). The FDA issued a Not Cleared (DENG) decision on April 18, 2005 after a review of 84 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5580 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Dental review framework.

FDA 510(k) Submission Details - DEN050001

510(k) Number DEN050001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 24, 2005
Decision Date April 18, 2005
Days to Decision 84 days
Submission Type Post-NSE
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · This submission: 84d
Pathway characteristics

NTO Device Classification - Class 2, Special Controls

Product Code NTO Rinse, Oral, Antibacterial (by Physical Means)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5580
Definition Antibacterial Oral Rinse That Is Used As An Aid In The Treatment Of Gingivitis, Acting By Physical Rather Than Chemical Means. The Rinse Works By Coating Tooth And Tissue Surfaces, Providing A Positive Charge That Reduces Bacterial Adhesion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

DEN050001 · DECAPINOL ORAL RINSE
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