Data / Medical devices / Taiwan / Enlighten Materials Co., Ltd.
Enlighten Materials Co., Ltd.: FDA-registered device maker in Taipei City, Taiwan, 2 510(k) clearances
Enlighten Materials Co., Ltd. is registered with the FDA (registration 3014778017) in Taipei City, Taiwan. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 18, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014778017
- Address
- 8F., No.138, Sec. 2, Jinshan S. RD., Da-An Dist., Taipei City, Taiwan, 10642
- Owner or operator
- Enlighten Materials Co., Ltd. (10079678)
- Roles
- Specification developer
- First device listed
- December 29, 2020
- Registered through
- 2026
- Brand names listed
- AA temp temporary restoration 3D printing photoreactive resin, BB Base 3D printing resin for denture base, CC tray 3D printing resin for individual tray, DD guide 3D printing resin for surgical guide
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 18, 2020 | K191591 | BB Base 3D printing resin for denture base | EBI | Substantially Equivalent | Enlighten Materials Co., Ltd. | accessdata.fda.gov |
| May 5, 2020 | K191590 | AA temp temporary restoration 3D printing photoreactive resin | EBG | Substantially Equivalent | Enlighten Materials Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Impression Tray, Resin
- All makers of Crown And Bridge, Temporary, Resin
Updated August 18, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.