Manufacturer registered with FDA
puracon GmbH
Rosenheim, Germany. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name puracon GmbH 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 | puracon GmbH | 6 device types | — | Below |
| Colombia | INVIMA | Manufacturer | PURACON GMBH | 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 puracon GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | endosseous implant, root formIMPLANT, ENDOSSEOUS, ROOT-FORM | 2015 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | endosseous implant, root formIMPLANT, ENDOSSEOUS, ROOT-FORM | 2015 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2018 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | — | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Bur | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | 2018 |
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 |
|---|---|---|
| PURACON GMBHFDA reg. 3004638532 | Rosenheim Bavaria, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028435). 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.