Manufacturer registered with FDA
Fabrinet Co., Ltd.
Klongluang, Thailand. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1Thailand
Registered in 4 markets
Where regulators' registries name Fabrinet Co., 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 | Fabrinet Co., Ltd. | 3 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Fabrinet Co., Ltd. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Fabrinet Co., Ltd | 2 | 2019–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Fabrinet Co., Ltd. | 1 | 2018–2018 | 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 Fabrinet Co., 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 |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | iTero Lumina | 2025 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Maker | iTero Lumina (Scanning unit) | 2025 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | iTero Lumina (Scanning unit) | 2025 |
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 |
|---|---|---|
| FABRINET CO., LTD.FDA reg. 3040278150 | Sriracha Chon Buri, Thailand | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9103440). 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.