Not currently registered with FDA under this name

Sinclair Pharmaceuticals Limited

Godalming, Surrey, United Kingdom. Named as applicant on 2 dental 510(k) clearances between 2005 and 2006. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22005–2006
Markets registered in
247 registrations outside the US
Establishments
0—
2005: 12006: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Sinclair Pharmaceuticals Limited as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesColombia: 47 registrations
RegisteredHome: United KingdomOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantSinclair Pharmaceuticals Limited2 clearances2005–2006Below
ColombiaINVIMARegistration holderSINCLAIR PHARMACEUTICALS LTDSINCLAIR PHARMACEUTICALS LIMITED47—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Sinclair Pharmaceuticals Limited as the applicant.

Decided510(k)DeviceDevice type
17 May 2006K053166SINCLAIR ORAL RINSENTO Antibacterial (by Physical Means) Oral Rinse
18 Apr 2005DEN050001DECAPINOL ORAL RINSENTO Antibacterial (by Physical Means) Oral Rinse

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.