Cleared Traditional

K053166 - SINCLAIR ORAL RINSE (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053166 · Sinclair Pharmaceuticals Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
184d
Days
Class 2
Risk

K053166 is an FDA 510(k) clearance for the SINCLAIR 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 Cleared decision on May 17, 2006 after a review of 184 days - an extended review cycle.

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 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 Sinclair Pharmaceuticals Limited devices

Submission Details

510(k) Number K053166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date May 17, 2006
Days to Decision 184 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 127d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.