Manufacturer registered with FDA
Technovent Limited
NEWPORT, United Kingdom. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 58 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 5 markets
Where regulators' registries name Technovent Limited 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 | Technovent Limited | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Technovent Limited | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TECHNOVENT LIMITEDTechnovent Limited | 2 | 2021–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Technovent Limited | 1 | 2022–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | TECHNOVENT 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 Technovent Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | MagnaCap abutment | 2012 |
| All Precision AttachmentEGG · Class 1 | — | Maker | MagnaCap System | 2000 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Technovent Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Factor, Ii, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Jan 2000 | K984297 | MAGNA ABUTMENT | Factor, Ii, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TECHNOVENT LIMITEDFDA reg. 9617078 | BRIDGEND, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9038802). 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.