Manufacturer registered with FDA
Shinhung Company, Ltd.
SEOUL, South Korea. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 14
- 510(k) clearances
- 22016–2023
- Markets registered in
- 1140 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Shinhung Company, 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 | Shinhung Company, Ltd. | 2 clearances | 2016–2023 | Below |
| Taiwan | TFDA | Manufacturer | SHINHUNG CO., LTD.Shinhung Company Ltd. | 9 | 2006–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Shinhung Company LtdShinhung Company Limited | 7 | 2015–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shinhung Co., Ltd. | 6 | — | Pure Global AI |
| China | NMPA | Registration holder | 株式会社新兴Shinhung Co., Ltd.株式会社新兴Shinhung Co.,Ltd. · 株式会社新兴 SHINHUNG Co., Ltd | 5 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SHINHUNG CO., LTD. | 4 | 2009–2013 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SHINHUNG CO., LTD | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SHINHUNG CO, LTD | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SHINHUNG CO.,LTDShinhung Co., Ltd., | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHINHUNG CO., LTD | 1 | 2023–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shinhung Company Ltd | 1 | — | 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 Shinhung Company, 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 |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | G7, Dental Operative Unit and AccessoriesTAURUS C1 | 2016 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | K-irrigator tipsSHINJECT | 2003 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | K-CLAMP | 2012 |
| Preformed CrownELZ · Class 1 | — | Maker | ALU CROWNKIDS CROWNKIDS GOLDEN CROWN, KIDS RING CROWN, KIDS ZIRCONIA CROWN TRY-INKIDS ZIRCONIA CROWNPERMA CROWNPERMA GOLDEN CROWNPrimary Molar S.S. CrownStainless Steel Primary Molar Crown | 2009 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Chair-C1, Chair-G7 | 2023 |
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 |
|---|---|---|
| SHINHUNG CO. LTD.FDA reg. 9710613 | Ansan-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9046958). 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.