Manufacturer registered with FDA
curasan AG
Kleinostheim, Germany. Lists 1 dental device type with FDA across 2 registered establishments, and holds 5 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 52005–2012
- Markets registered in
- 12145 registrations outside the US
- Establishments
- 2Germany
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name curasan AG 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 | curasan AG | 5 clearances | 2005–2012 | Below |
| European Union | EUDAMED | Manufacturer | curasan AG | 66 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CURASAN AG | 17 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | CURASAN AG | 11 | 2010–2018 | Pure Global AI |
| Israel | AMAR | Manufacturer | Curasan AG | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CURASAN AGCurasan AG | 11 | 2006–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | curasan AG | 10 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Curasan AGcurasan AG | 7 | 2001–2013 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CURASAN AG | 5 | 2008–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Curasan AG | 3 | — | Pure Global AI |
| China | NMPA | Registration holder | 科卢森股份公司curasan AG | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Curasan AG | 2 | — | 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 curasan AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | Ceracell DentalCERASORB BioactiveCerasorb DentalIngeniOs Beta-TCP BioactiveIngeniOs HAOsbone DentalOsseolive DENTAL | 2010 |
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 curasan AG as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Dec 2012 | K111105 | CURASAN OSSEOLIVE DENTAL | LYC Synthetic Bone Grafting Material |
| 10 Mar 2011 | K103709 | CERACELL DENTAL | LYC Synthetic Bone Grafting Material |
| 12 Jan 2011 | K102872 | OSBONE DENTAL | LYC Synthetic Bone Grafting Material |
| 11 Jun 2007 | K063106 | REVOIS IMPLANT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 22 Jul 2005 | K051443 | CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CURASAN AGFDA reg. 3003771570 | KLEINOSTHEIM Bavaria, Germany | Specification developer |
| CURASAN AG, FRANKFURT FACILITYFDA reg. 3004847139 | FRANKFURT Hesse, Germany | Manufacturer |
Other names on FDA records
Curasan Ag, Frankfurt Facility
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034158). 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.