Manufacturer registered with FDA
EC Certification Service GmbH
St. Veit/Glan, Austria. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 13
- 510(k) clearances
- 12025–2025
- Markets registered in
- 611 registrations outside the US
- Establishments
- 1Austria
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name EC Certification Service 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 | EC Certification Service GmbH | 1 clearances | 2025–2025 | Below |
| United Kingdom | MHRA | Manufacturer | EC Certification Service GmbH | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EC CERTIFICATION SERVICE GMBH | 2 | 2016–2016 | Pure Global AI |
| Australia | TGA | Manufacturer | EC Certification Service GmbH | 1 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | EC Certification Service GmbH | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | EC Certification Service GmbH | 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 EC Certification Service 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 |
|---|---|---|---|---|
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Maker | ClearClear PlusECC Premium LineLarson RadiusRing ButtonShark 80Shark SLSquare ButtonTriple Edge BracketTriple Edge Button 2 moreTurrin AFCXpert | 2025 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | — | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Metal Triple Edge Button | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names EC Certification Service GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Apr 2025 | K251196 | Composite Orthodontic Brackets and Buttons | DYW Orthodontic Plastic Bracket |
Some of these clearances are listed with FDA today by another company: KLOwen Braces dba KLOwen Orthodontics (1), Young Innovations Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EC Certification Service GmbHFDA reg. 3008796797 | St. Veit/Glan Karnten, Austria | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035465). 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.