Manufacturer registered with FDA
Surgident Co., Ltd.
Dong-gu, South Korea. Lists 9 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 82
- 510(k) clearances
- 22018–2019
- Markets registered in
- 743 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Surgident 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 | Surgident Co., Ltd. | 2 clearances | 2018–2019 | Below |
| United Kingdom | MHRA | Manufacturer | SURGIDENT CO., LTD | 17 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SURGIDENTSURGIDENT CO., LTD. · SURGIDENT CO. · +2 | 13 | 2012–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Surgident Co Ltd | 7 | 2019–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SURGIDENT CO LTD | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Surgident Co., Ltd | 2 | — | Pure Global AI |
| China | NMPA | Registration holder | 赛吉登特有限公司Surgident Co., 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 Surgident 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 |
|---|---|---|---|---|
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | GBR System SD-Screw, Bone TacGBR System Titanium Mesh | 2018 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | DR.PARK Needle HolderDR.PARK Tissue Forceps | 2026 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Maker | Driver HandleMalletTac ApplicatorTac Remover Driver | 2017 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental BurNLBC DrillNLBC StopperPilot DrillSD Bone Profiler | 2017 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | SERENITI | 2020 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | GBR System SD-Screw, Bone TacGBR System Titanium Mesh | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AQUA TOCA KITBASIC KITBONE EXPANDER KITBONE MILLBONE MULTI SYSTEMBONE SPREADING KITC&L SINUS KITContra TorqueCrestal Sinus Lift KitDigital Sinus Guide Kit 54 moreDr. Sam Lee 3 in 1 kitDr. Sam Lee Basic setDr. Sam Lee Ultimate Crestal&Lateral kitDrill Stop KitEasy Bone Expander KitEASY SINUS KITFixture Driver SetFIXTURE REMOVER KITFIXTURE&SCREW REMOVER KITGUIDED SURGERY KITHandpiece ApplicatorIMPLANT CLEANING BRUSHIMPLANT POSITIONING KITImplant Prosthetic Driver AssortmentIMPLANT PROSTHETIC DRIVER KITIMPLANT PROSTHETIC DRIVER KIT IIImplant Removal Kit Gen IILATERAL WALL SINUS KITMP20NEVER LOSS BONE COLLECTOROSTEOTOME R-SETOSTEOTOME S-SETP.R.F SYSTEMP.R.P-MEMBRANE KITPower Easy Bone Expender KitPOWERTOME KITPre-Expansion AssortmentRidge Expansion KitRIDGE SPLIT SETSAVE REMOVER KITScrew Fixation KitSCREW REMOVER KITSD Abutment - Abutment Screw DriverSD Abutment - Impression CopingSD Abutment- AnalogSD REAMER SETSD-TORQUESD-Torque1.28SD-TORQUELESSShatkin F.I.R.S.T Sinus Lift KitSINGLE-OUTSinus Expansion Drill KitSTOP DRILL KITSurgical Guide Kit -ZMSystem of Torque DriverTissue Punch AssortmentTOCA KITTOLA KITTOLA KIT IITOP SYSTEMTrephine Bur AssortmentTRIMMER KITWATER RISING SYSTEM3S SET | 2017 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | SD Abutment | 2019 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dental operative unit&accessories | 2017 |
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 |
|---|---|---|
| SURGIDENT CO., LTD.FDA reg. 3009551666 | Dong-gu Daegu, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056549). 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.