Registered with FDA
EdelweissDR AG
Zug, Switzerland. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1Switzerland
Registered in 3 markets
Where regulators' registries name EdelweissDR AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | EdelweissDR AG | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Edelweiss DR AG | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Edelweiss DR AG | 1 | 2015–2015 | 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 EdelweissDR AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2014 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
EdelweissDR AG lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dmg USA, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 May 2008 | K080480 | NANOCOMPOSITE RESTORATIVE KIT | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EDELWEISSDR AGFDA reg. 3011148229 | Zug, Switzerland | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047324). 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.