Manufacturer registered with FDA
Smilecad
Dongnae-gu, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Smilecad 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 | NT-TAINER | 2026 |
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 |
|---|---|---|
| SMILECADFDA reg. 3045823938 | Dongnae-gu Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096002). 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.