Manufacturer registered with FDA
Graphenano Dental, SL
Yecla, Spain. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 22022–2025
- Markets registered in
- 56 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Graphenano Dental, SL 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 | Graphenano Dental, SL | 2 clearances | 2022–2025 | Below |
| Australia | TGA | Manufacturer | Graphenano Dental SL | 2 | 2021–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GRAPHENANO DENTAL SL | 2 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | GRAPHENANO DENTAL, S.L. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Graphenano Dental | 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 Graphenano Dental, SL 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 | G-CAMGRAPHENANO DENTAL | 2022 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | G-CAM | 2022 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | G-CAM | 2022 |
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 |
|---|---|---|
| GRAPHENANO DENTAL, SLFDA reg. 3017183443 | Paterna Valencia(Province), Spain | Complaint file establishment, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084283). 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.