Manufacturer registered with FDA
Enlighten Materials Co., Ltd.
Taipei City, Taiwan. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 22020–2020
- Markets registered in
- 25 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Enlighten Materials 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 | Enlighten Materials Co., Ltd. | 2 clearances | 2020–2020 | Below |
| Brazil | ANVISA | Manufacturer | ENLIGHTEN MATERIALS CO LTD. | 5 | 2019–2020 | 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 Enlighten Materials 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 |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | AA temp temporary restoration 3D printing photoreactive resin | 2020 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | CC tray 3D printing resin for individual tray | 2020 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | BB Base 3D printing resin for denture base | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DD guide 3D printing resin for surgical guide | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Enlighten Materials Co., Ltd. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ENLIGHTEN MATERIALS CO., LTD.FDA reg. 3014778017 | Taipei City, Taiwan | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079678). 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.