Manufacturer registered with FDA
Theia Holding SA
La Chaux-de-Fonds, Switzerland. Lists 6 dental device types with FDA across 2 registered establishments.
- Device types listed
- 6
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 211 registrations outside the US
- Establishments
- 2Switzerland, Ireland
Registered in 2 markets
Where regulators' registries name Theia Holding SA 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 | Theia Holding SA | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Hader Solutions and Distribution LTD | 11 | — | 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 Theia Holding SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| All Precision AttachmentEGG · Class 1 | — | Maker | HADER ATTACHMENTS | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DriverFlexDrive Drive HolderIMPLANT BUDDYImplantBuddy FlexDrive Edition | 2011 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2023 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2023 |
| Preformed BarEHO · Class 1 | — | Maker | HADER ATTACHMENTS | 2011 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Maker | FlexDrive® Prosthetic KitFlexDrive® Surgical Kit | 2026 |
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 |
|---|---|---|
| HADER Solutions & Distribution LtdFDA reg. 3026401444 | Swords CO Dublin Dublin(County), Ireland | Manufacturer |
| Theia Holding SAFDA reg. 3001110146 | La Chaux-de-Fonds Neuchatel, Switzerland | Contract manufacturer |
Other names on FDA records
Hader Solutions and Distribution LTD
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10038408). 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.