Registered with FDA
HI Medical Co., Ltd.
SEOUL, South Korea. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What HI 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 | Lister | GC3M ESPE | 2017 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Kulzer3M ESPE | 2020 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | 3M ESPE | 2020 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Dentsply | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | GC | 2018 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | Dentsply | 2017 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Dentsply | 2026 |
| Preformed CrownELZ · Class 1 | — | Lister | 3M ESPE | 2018 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | Dentsply | 2026 |
| Resin ApplicatorKXR · Class 1 | — | Lister | Young Innovations | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | Denstply | 2023 |
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
HI 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: 3M Espe AG Dental Products (2), Sino-Dentex Co., Ltd. (1), Dentsply Sirona, Inc. (1), 3M Espe Dental Products (1), GC America Inc. (1), Heraeus Kulzer, LLC (1), Espe Dental AG (1), Espe GmbH & Co. Kg. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Sep 2023 | K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | KLE Resin Tooth Bonding Agent |
| 2 Sep 2020 | K193405 | Simplant Digital Guide | Dentsply Sirona, Inc. | NDP Endosseous Dental Implant Accessories |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 8 Apr 2010 | K094007 | UNICEM | 3M Espe AG Dental Products | EMA Dental Cement |
| 24 Apr 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products | KLE Resin Tooth Bonding Agent |
| 17 Jul 2000 | K001730 | GC FUJICEM | GC America Inc. | EMA Dental Cement |
| 5 Apr 2000 | K000629 | FLEXTIME | Heraeus Kulzer, LLC | ELW Impression Material |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | Espe Dental AG | ELW Impression Material |
| 17 Nov 1997 | K973262 | KETAC-FIL APLICAP PLUS | Espe GmbH & Co. Kg. | EMA Dental Cement |
| 23 Jul 1992 | K922721 | VLC DYCAL II | Dentsply Intl., Inc. | EJK Calcium Hydroxide Cavity Liner |
| 31 Oct 1988 | K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | Coe Laboratories, Inc. | EMA Dental Cement |
| 18 Mar 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HI MEDICAL CO., LTD.FDA reg. 3012502601 | SEOUL, South Korea | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052106). 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.