Manufacturer registered with FDA
Creamed GmbH & Co. Produktions- und Handels KG
Marburg, Germany. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 12022–2022
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Creamed GmbH & Co. Produktions- und Handels 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 | Creamed GmbH & Co. Produktions- und Handels KG | 1 clearances | 2022–2022 | Below |
| Australia | TGA | Manufacturer | creamed GmbH & Co Produktions-und Handels KG | 2 | 2023–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | creamed GmbH&Co. Produktions- und Handels KG | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Creamed GmbH & Co. Produktions-und Handels KG | 1 | 2014–2014 | 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 Creamed GmbH & Co. Produktions- und Handels 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 |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | AMBARINOENA CADENACAD | 2013 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | AMBARINOENA CAD | 2013 |
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
Creamed GmbH & Co. Produktions- und Handels KG 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: Dental Laboratory Milling Supplies, LLC (Dlms) (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Sep 2013 | K130654 | CRYSTAL ULTRA | Dental Laboratory Milling Supplies, LLC (Dlms) | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CREAMED GMBH & CO. PRODUKTIONS- UND HANDELS KGFDA reg. 3009907932 | Marburg Hesse, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045561). 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.