Manufacturer registered with FDA
Shinhung Mst Co., Ltd.
Wonju Si, South Korea. Lists 8 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 722
- 510(k) clearances
- 72013–2023
- Markets registered in
- 5757 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Shinhung Mst Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shinhung Mst Co., Ltd. | 7 clearances | 2013–2023 | Below |
| European Union | EUDAMED | Manufacturer | Shinhung MST Co., Ltd. | 745 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Shinhung MST Co., Ltd. | 5 | 2013–2016 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shinhung MST Co. Ltd. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 新兴美斯特SHINHUNG MST CO., LTD.新兴美斯特SHINHUNG MST CO.,LTD. | 3 | — | 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 Mst 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | MagDen Implant SystemSISMST | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | MagDen Implant SystemSISMST | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | AD10CDRCDW / Cortical DrillFDRFDWGCB35GCB40GCB45GCB50GFD3507 209 moreGFD3508GFD3510GFD3511GFD3513GFD40GFD4007GFD4008GFD4010GFD4011GFD4013GFD4507GFD4508GFD4510GFD4511GFD4513GFD5004GFD5005GFD5006GFD5007GFD5008GFD5010GFD5011GFD5013GID2604GID2605GLD2607GLD2608GLD2610GLD2611GLD2613GPD5004GPD5005GPD5006GSIDSID226ID356LCB35LCB40LCB45LCB50LCB50SLCB60LITD35DLITD40DLITD45DLITD50DLITD60DLLD2307LLD2308LLD2310LLD2311LLD2313LLD2315LSD3507LSD3508LSD3510LSD3511LSD3513LSD3515LSD4007LSD4008LSD4010LSD4011LSD4013LSD4015LSD4507LSD4508LSD4510LSD4511LSD4513LSD4515LSD5007LSD5008LSD5010LSD5011LSD5013LSD5015LSK02LSSSK01NCB50NSSD3507NSSD3508NSSD3510NSSD3511NSSD3513NSSD3515NSSD4007NSSD4008NSSD4010NSSD4011NSSD4013NSSD4015NSSD4507NSSD4508NSSD4510NSSD4511NSSD4513NSSD4515NSSD5007NSSD5008NSSD5010NSSD5011NSSD5013NSSD5015RKRRDRKSRDNRKSRDRSBPI62SBPN42SBPN50SBPN50ASBPR52SBPR55SBPR55ASBPR62SBPR65SBPR65ASBPW62SD10SD11SD13SD70SD85SIDR20SIDR27SIDR2802SIDR2803SIDR2804SIDR32SIDR37SIDR42SITD7503SKRP32SKRP37SKRP42SLD27LSLD27SSLD32LSLD32SSLD37L | 2013 |
| All Precision AttachmentEGG · Class 1 | — | Maker | BAA45EBCN5042HEBCN5044HEBCN5064HEBCN5066HEBCR5042HEBCR5044HEBCR5064HEBCR5066HEBCSN42 242 moreEBCSN44EBCSN64EBCSN66EBCSR42EBCSR44EBCSR64EBCSR66EBCSW42EBCSW44EBCSW64EBCSW66EBCW5042HEBCW5044HEBCW5064HEBCW5066HSAA40SAA45SAA55SAPU40SAPU40HSAPU45SAPU45HSAPU55SAPU55HSAPUS18SAT40SAT40HSAT45SAT45HSAT55SAT55HSATS18SBCN5042HSBCN5043HSBCN5044HSBCN5064HSBCN5066HSBCR5042HSBCR5043HSBCR5044HSBCR5045HSBCR5064HSBCR5065HSBCR5066HSBCR6043HSBCR6044HSBCR6045HSBCR6064HSBCR6065HSBCR6066HSBCSN42SBCSN43SBCSN44SBCSN64SBCSN66SBCSR42SBCSR43SBCSR44SBCSR45SBCSR64SBCSR65SBCSR66SFAN35SFAR40SFPUN40HLSFPUN40HSSFPUN40LSFPUN40SSFPUR40HLSFPUR40HSSFPUR40LSFPUR40SSFPUR50HLSFPUR50HSSFPUR50LSFPUR50SSFPUR60HLSFPUR60HSSFPUR60LSFPUR60SSFTN40HLSFTN40HSSFTN40LSFTN40SSFTR40HLSFTR40HSSFTR40LSFTR40SSFTR50HLSFTR50HSSFTR50LSFTR50SSFTR60HLSFTR60HSSFTR60LSFTR60SSFTSN00LSFTSN00SSFTSR00LSFTSR00SSPP40SPP40HSPP45SPP45HSPP55SPP55HSPUSN00LSPUSN00SSPUSR00LSPUSR00SSSPAA4040SSPAA4055SSPAA4070SSPAA4540SSPAA4555SSPAA4570SSPAA5040SSPAA5055SSPAA5070SSPAA6040SSPAA6055SSPAA6070SSPAC40SSPAC45SSPAC50SSPAC60SSPBC40BSSPBC40SSSPBC45BSSPBC45SSSPBC50BSSPBC50SSSPBC60BSSPBC60SSSPICC4055SSPICC4555SSPICC5055SSPICC6055STAN4010HPSTAN4010P | 2008 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | BAT00SPICC40SPICC45SPICC55SPICC65 | 2008 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | ADH10ASLASSBCD14BCD18DE10DG00DI00LDI00SDI4L 192 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 / Sleeve for S-GuideSTDKSTHFD01ELSTHFD01L | 2008 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | DS40DS50SHMLLSHMLSSHSCSHSC1SHSC2SHSC3SIST02SIST03 15 moreSIST04SIST05SIST06SIST07SIST08SIST09SIST10SIST11SIST12SKBC00SKBP00SKDG00SSCA00SSGKST32 | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | MRTNMRTRPBC40SSPBC40BSPBC45BSPBC45SSPBC55SSPBC65BSPBC65SSSG53C 1 moreSSG53P | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Shinhung Mst Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Jun 2023 | K221752 | Stella | DZE Root-Form Endosseous Implant |
| 3 Feb 2023 | K223395 | Luna Dental Implant System | NHA Endosseous Dental Implant Abutment |
| 13 Jan 2023 | K221317 | S-Mono | DZE Root-Form Endosseous Implant |
| 26 Feb 2020 | K200189 | Luna Dental Implant System- Healing Abutment | NHA Endosseous Dental Implant Abutment |
| 26 Jul 2017 | K162867 | MagDen Dental Implant System | DZE Root-Form Endosseous Implant |
| 26 Aug 2016 | K160106 | LUNA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 31 Oct 2013 | K123155 | LUNA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Shinhung MST Co., Ltd.FDA reg. 3006948193 | Wonju Si Gangwon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024874). 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.