Data / Medical devices / Taiwan / Smilden Biotechnology Co., Ltd.
Smilden Biotechnology Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Smilden Biotechnology Co., Ltd. is registered with the FDA (registration 3011500388) in New Taipei City, Taiwan. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 28, 2014. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011500388
- Address
- 7F, NO.186, Jian 1st Rd., Chung Ho District, New Taipei City, Taiwan, 23553
- Owner or operator
- Smilden Biotechnology CO., Ltd. (10091129)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- July 9, 2024
- Registered through
- 2026
- Brand names listed
- Alloy, Metal, Base, Alloy, gold-based noble metal, Attachment, Precision, All, Bluem tooth brush, Crown, Performed, DM03 Model Resin, Denture, Plastic, Teeth, Dentures, Full and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Gold-Based Noble Metal | EJT | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Manufacturer | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| May 28, 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Alloy, Gold-Based Noble Metal
- All makers of Attachment, Precision, All
- All makers of Crown, Preformed
- All makers of Alloy, Metal, Base
- All makers of Dentures, Partial
- All makers of Material, Impression
Updated May 28, 2014. 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.