510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K053166Substantially Equivalent

Sinclair Oral Rinse

Sinclair Pharmaceuticals Ltd, Godalming, Surrey, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053166 is the FDA 510(k) clearance record for SINCLAIR ORAL RINSE, a class II device, cleared for Sinclair Pharmaceuticals Limited on under FDA product code NTO (Rinse, Oral, Antibacterial (By Physical Means)). FDA's definition for product code NTO reads: "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". FDA records list 10 510(k) clearances for Sinclair Pharmaceuticals Limited, from to . As of , FDA records show no recalls naming K053166.

Clearance record

Decision date
Received
(184 days to decision)
Product code
NTO Rinse, Oral, Antibacterial (By Physical Means)
Regulation
21 CFR 872.5580
Device class
Class II
Review panel
Dental
Applicant
Sinclair Pharmaceuticals Limited Borough Rd., Godalming, Surrey, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTO

Trailing 12 months

FDA records hold no clearances under product code NTO in the trailing twelve months.

FDA records show no clearances under product code NTO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260