Manufacturer registered with FDA
Smilden Biotechnology CO., Ltd.
New Taipei City, Taiwan. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Taiwan
Devices listed with FDA
What Smilden Biotechnology 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Retainer | 2024 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | DM03 Model Resin | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Bluem tooth brush | 2026 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Attachment, Precision, All | 2024 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Alloy, Metal, Base | 2024 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | Alloy, gold-based noble metal | 2024 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Denture, Plastic, Teeth | 2024 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | PERFIT | 2024 |
| Preformed CrownELZ · Class 1 | — | Maker | Crown, Performed | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Smilden Biotechnology CO., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Rizhao Huge Dental Industry Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 May 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | Rizhao Huge Dental Industry Co., Ltd. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMILDEN BIOTECHNOLOGY CO., LTD.FDA reg. 3011500388 | New Taipei City, Taiwan | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091129). 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.