Manufacturer registered with FDA
Haleon
Warren, NJ, United States. Lists 4 dental device types with FDA across 4 registered establishments.
- Device types listed
- 4
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 421 registrations outside the US
- Establishments
- 4Ireland, United States
Registered in 4 markets
Where regulators' registries name Haleon 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 | Haleon | 4 device types | — | Below |
| Japan | PMDA | Registration holder | Ｈａｌｅｏｎジャパン株式会社 | 15 | 2007–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HALEON US INC. | 4 | 2021–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Haleon US Inc. | 2 | — | 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 Haleon 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 CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | DENTURE CLEANSERS (VARIOUS)PolidentPolident 3 Minute: Antibacterial Dental Appliance CleanserPolident CleanerPolident Overnight Whitening: Antibacterial Dental Appliance CleanserPolident Rapid Clean: Antibacterial Dental Appliance CleanserPolident Smokers: Antibacterial Dental Appliance CleanserPOLIGRIP DENTURE CLEANSER TABLETS | 2002 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | parodontax COMPLETE PROTECTION TOOTHBRUSHParodontax ToothbrushPolident Denture Cleaner BrushSensodyne Pronamel Enamel Protection Medium ToothbrushSensodyne Pronamel Intensive Enamel Repair Soft ToothbrushSensodyne Sensitive Care ToothbrushSensodyne Sensitivity & Gum Soft Toothbrush | 2010 |
| Carboxymethylcellulose Sodium (32%) and Ethylene-Oxide Homopolymer Denture AdhesiveKOL · Class 1 | — | Maker | POLIGRIP DENTURE ADHESIVEPoligrip Power Max Ultimate All in 1 | 2010 |
| Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1 | Denture cleansers & adhesives | Maker | SUPER POLIGRIP FREE CREAM | 2010 |
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 |
|---|---|---|
| Haleon US Holdings LLCFDA reg. 1314819 | East Durham, NY, United States | Manufacturer |
| Haleon US HOLDINGS LLCFDA reg. 3012293198 | Warren, NJ, United States | Specification developer |
| Haleon US Inc.FDA reg. 1911445 | Lincoln, NE, United States | Manufacturer |
| Stafford-Miller LimitedFDA reg. 1000415764 | DUNGARVAN Waterford(County), Ireland | Manufacturer |
Other names on FDA records
Haleon US Inc. · Haleon US HOLDINGS LLC · Stafford-Miller Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2510369). 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.