Manufacturer registered with FDA
Smile Dental Laboratory Company Limited
Zhuhai, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Smile Dental Laboratory Company Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Custom Tray | 2023 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | NP CROWN AND BRIDGE | 2023 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | PARTIAL DENTURE | 2023 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Flexible,Partial and Full Denture | 2023 |
| Preformed Gold Denture TeethELN · Class 1 | — | Maker | FCG | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMILE DENTAL LABORATORY COMPANY LIMITEDFDA reg. 3020052762 | Zhuhai Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088359). 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.