FDA Registration
Active
🇹🇼 Taiwan
ENLIGHTEN MATERIALS CO., LTD.
Reg #: 3014778017
·
FEI: 3014778017
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ENLIGHTEN MATERIALS CO., LTD.
- Registration Number
- 3014778017
- FEI Number
- 3014778017
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8F., NO.138, SEC. 2, JINSHAN S. RD., DA-AN DIST.,
- City
- Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K191591
Owner / Operator
- Firm Name
- Enlighten Materials Co., Ltd.
- Operator Number
- 10079678
- Address
- 8F., NO.138, SEC. 2, JINSHAN S. RD., DA-AN DIST.,
- City
- Taipei City
- State
- TW-TPE
- Postal Code
- 10642
- Country
- TW
- Correspondent
- Jiun Ming Su
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2020-12-29 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2020-12-29 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-12-29 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2020-12-29 |
Proprietary Names
CC tray 3D printing resin for individual tray
BB Base 3D printing resin for denture base
DD guide 3D printing resin for surgical guide
AA temp temporary restoration 3D printing photoreactive resin
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility