Manufacturer registered with FDA
Prima Dental Group
GLOUCESTER, ENGLAND, United Kingdom. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 3 markets
Where regulators' registries name Prima Dental Group 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 | Prima Dental Group | 5 device types | — | Below |
| Taiwan | TFDA | Manufacturer | PRIMA DENTAL GROUP | 5 | 2006–2012 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PRIMA DENTAL GROUP | 1 | 2012–2012 | 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 Prima Dental Group currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Predator Zirconia DiamondsPrima Classic Diamonds | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 1998 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Polisher, DentalPrima Dental Illume | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 2003 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Prima One GoldPrima TaperPrima Taper Gold | 2019 |
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 |
|---|---|---|
| PRIMA DENTAL GROUPFDA reg. 3003444492 | GLOUCESTER Gloucestershire, United Kingdom | Contract manufacturer, Manufacturer, Remanufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9028341). 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.