Manufacturer registered with FDA
steco-system-technik GmbH & Co KG
HAMBURG, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 614 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name steco-system-technik GmbH & Co KG 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 | steco-system-technik GmbH & Co KG | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | STECO-SYSTEM-TECHNIK GMBH & CO. KG | 5 | 2009–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | steco-system-technik GmbH & co. KG | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | steco-system-technik GmbH & Co KG | 2 | 2018–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | steco-system-technik GmbH & Co. KG | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | steco-System-Technik GmbH & Co. KG | 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 steco-system-technik GmbH & Co KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| All Precision AttachmentEGG · Class 1 | — | Maker | Titanmagnetics | 1999 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | StecoGuide | 2011 |
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 |
|---|---|---|
| STECO-SYSTEM-TECHNIK GMBH & CO. KGFDA reg. 9617660 | HAMBURG, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9036825). 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.