Manufacturer registered with FDA
Ceramisys Ltd
Sheffield, United Kingdom. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 12011–2011
- Markets registered in
- 1143 registrations outside the US
- Establishments
- 1United Kingdom
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Ceramisys Ltd 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 | Ceramisys Ltd | 1 clearances | 2011–2011 | Below |
| Colombia | INVIMA | Manufacturer | CERAMISYS LTDCERAMISYS LIMITED · CERAMISYS LTD. | 13 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | CERAMISYS LIMITED | 6 | 2006–2013 | Pure Global AI |
| Israel | AMAR | Manufacturer | Ceramisys LtdCERAMISYS LTD · Ceramisys Ltd. | 6 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | .Ceramisys Ltd,Ceramisys Ltd., | 4 | 2023–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Ceramisys Ltd | 3 | 2013–2017 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CERAMISYS LIMITED | 3 | 2007–2017 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ceramisys Ltd | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CERAMISYS Ltd. | 2 | 2022–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ceramisys Ltd | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Ceramisys Limited | 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 Ceramisys Ltd 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 | ReproBone¿ SyntheticResorbable Bone Graft Substitute | 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 |
|---|---|---|
| CERAMISYS LTDFDA reg. 3007708799 | Sheffield York, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029778). 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.