Manufacturer registered with FDA
SHIKEN Co.,Ltd.
Osaka-shi, Japan. 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
- 1Japan
Devices listed with FDA
What SHIKEN 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Soladey | 2008 |
| Battery-Powered Ionic ToothbrushMMD · Class 1 | Toothbrushes | Maker | Soladey Rhythm 2 | 2021 |
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 |
|---|---|---|
| SHIKEN CO.,LTD.FDA reg. 3006691310 | Osaka, Japan | Foreign exporter, Private-label distributor, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024612). 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.