Manufacturer registered with FDA
Dentaco GmbH & Co. KG
Essen, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 54 registrations outside the US
- Establishments
- 1Germany
Registered in 5 markets
Where regulators' registries name Dentaco 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 | Dentaco GmbH & Co. KG | 3 device types | — | Below |
| Australia | TGA | Manufacturer | Dentaco GmbH & Co KG | 1 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dentaco GmbH & Co.KG | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Dentaco GmbH & Co. KG | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DENTACO 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 Dentaco 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 |
|---|---|---|---|---|
| Articulation PaperEFH · Class 1 | — | Maker | ACCUFILM IV | 2000 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Boca BiteScan Bite | 2009 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | E4D AccentIPS Contrast Spray chairsidescan dryScan dry plusScan liquidScan Sprayscan spray luer | 2010 |
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 |
|---|---|---|
| DENTACO GmbH & Co. KGFDA reg. 8010827 | Essen North Rhine-Westphalia, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010827). 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.