Manufacturer registered with FDA
Sun Medical Co., Ltd.
Moriyama-shi, Japan. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 22015–2015
- Markets registered in
- 320 registrations outside the US
- Establishments
- 1Japan
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Sun Medical Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sun Medical Co., Ltd. | 2 clearances | 2015–2015 | Below |
| Taiwan | TFDA | Manufacturer | SUN MEDICAL CO., LTD.SUNMEDICAL CO., LTD. | 18 | 2006–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SUN MEDICAL CO. LTD | 2 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sun Medical 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 |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | iCEM Universal Plus | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sun Medical Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Kulzer, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Dec 2025 | K254063 | iCEM Universal Plus | Kulzer, LLC | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUN MEDICAL CO., LTD.FDA reg. 8030419 | Moriyama Shiga, Japan | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094760). 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.