Manufacturer registered with FDA
Matricel GmbH
Herzogenrath, Germany. Lists 1 dental device type with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 12014–2014
- Markets registered in
- 1016 registrations outside the US
- Establishments
- 2Germany
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Matricel 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 | Matricel GmbH | 1 clearances | 2014–2014 | Below |
| Israel | AMAR | Manufacturer | Matricel GmbHMatricel Gmbh | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Matricel GmbH | 2 | 2026–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | MATRICEL GMBH | 2 | 2015–2015 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MATRICEL GMBH | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Matricel GmbH | 2 | 2016–2016 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Matricel GmbH | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MATRICEL GMBH | 1 | 2026–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Matricel GmbH | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Matricel GmbH | 1 | 2013–2013 | 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 Matricel 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 |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | creos xenoprotectKontour MatrixZmatrix | 2014 |
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 |
|---|---|---|
| Matricel GmbHFDA reg. 3019834892 | Herzogenrath North Rhine-Westphalia, Germany | Manufacturer |
| MATRICEL GMBHFDA reg. 3007113424 | Herzogenrath North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10026736). 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.