Manufacturer registered with FDA
Sheffield Pharmaceuticals LLC
New London, CT, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 411 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Sheffield Pharmaceuticals LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sheffield Pharmaceuticals LLC | 3 device types | — | Below |
| Taiwan | TFDA | Manufacturer | SHEFFIELD PHARMACEUTICALSSHEFFIELD PHARMACEUTICALS LLC | 8 | 2007–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sheffield Pharmaceuticals | 2 | 2007–2013 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHEFFIELD PHARMACEUTICALS | 1 | — | 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
Devices listed with FDA
What Sheffield Pharmaceuticals LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | ACRYLINE Denture reliner | 2016 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Cleanadent | 2021 |
| Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1 | Denture cleansers & adhesives | Maker | Combe Denture Adhesive CreamDawn Mist Denture AdhesiveDr. Berland's Adhesadent Moisturizing Denture AdhesiveDr. Sheffield Staydent AdhesiveEquate Complete Denture AdhesiveEquate Super Hold Denture Adhesive creamFamily Dollar Denture AdhesiveLife Brand Denture AdhesiveLife Brand Mint Denture AdhesivePremier Value Denture Adhesive 1 moreQuality Choice Denture Adhesive Cream | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Sheffield Pharmaceuticals LLCFDA reg. 1210513 | NEW LONDON, CT, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1210513). 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.