Manufacturer registered with FDA
SMD Solution Co., Ltd.
Seoul, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What SMD Solution 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | COMORAL Oral Irrigation Unit | 2019 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Comoral HComoral Oral Irrigation Unit | 2019 |
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 |
|---|---|---|
| SMDsolutions Corp.FDA reg. 3015532219 | Seoul, South Korea | Manufacturer |
Other names on FDA records
SMDsolutions Corp.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060799). 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.