Manufacturer registered with FDA
Smart Dental Cad Solutions Limited
Zhuhai, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Smart Dental Cad Solutions 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 |
|---|---|---|---|---|
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | Restoration, Noble Metal | 2023 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | Ti implant abutment | 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 |
|---|---|---|
| SMART DENTAL CAD SOLUTIONS LIMITEDFDA reg. 3030254056 | Zhuhai Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089554). 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.