Manufacturer registered with FDA
Seilglobal CO., Ltd
Busan, South Korea. Lists 10 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 10
- Brands and models
- 15
- 510(k) clearances
- 12015–2015
- Markets registered in
- 629 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Seilglobal 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 | Seilglobal CO., Ltd | 1 clearances | 2015–2015 | Below |
| Taiwan | TFDA | Manufacturer | SEIL GLOBAL CO., LTD.SEIL GLOBAL CO., LTD · SEILGLOBAL CO., LTD. | 15 | 2005–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Seil Global | 7 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Seil Global Co LtdSeilGlobal | 5 | 2010–2014 | Pure Global AI |
| Israel | AMAR | Manufacturer | Seil Global Co. Ltd. | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SEILGLOBAL CO., LTD. | 1 | 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 Seilglobal 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mirror system | 2014 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Disposable Impression TrayJB Tray, JBUT, JBLT, JBUTLT, JBUTR, JBLTR | 2014 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Autoclavable Irrigation Tube | 2024 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Composite SyringeDual SyringeFlow Syringe | 2025 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Cartridge 50mDentiAnn Imp Save SyringeDentiAnn Impression Saver | 2025 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | DentiAnn Smart Sil | 2015 |
| Preformed CrownELZ · Class 1 | — | Maker | Primary Crown | 2021 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | ZirADD | 2025 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Maker | auto mix tip | 2014 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | ADD POP BOW | 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 |
|---|---|---|
| SEILGLOBAL CO., LTDFDA reg. 3007353764 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045865). 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.