Manufacturer registered with FDA
SNUCONE Co., LTD.
Dalseo-gu, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 79
- 510(k) clearances
- 22022–2023
- Markets registered in
- 6917 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name SNUCONE 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 | SNUCONE Co., LTD. | 2 clearances | 2022–2023 | Below |
| European Union | EUDAMED | Manufacturer | SNUCONE CO., LTD. | 886 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Snucone Co.Ltd | 18 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SNUCONE CO.LTD.SNUCONE CO. LTD. | 8 | 2017–2022 | Pure Global AI |
| China | NMPA | Registration holder | 韩国仕诺康株式会社SNUCONE Co., Ltd.韩国仕诺康株式会社SNUCONE CO., LTD | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SNUCONE Co. Ltd. | 2 | — | 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 SNUCONE 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | SNUCONE BONE LEVEL IMPLANT SYSTEMSNUCONE TISSUE LEVEL IMPLANT SYSTEM | 2022 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | SNUCONE BONE LEVEL IMPLANT SYSTEMSNUCONE TISSUE LEVEL IMPLANT SYSTEM | 2022 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | BONE FLATTENERBONE TRIMMERCOUNTER SINKGUIDE COUNTER SINK PROFILERGUIDE PILOT DRILLGUIDE PIN DRILLGUIDE START DRILLGUIDE TIP TWIST DRILLGUIDE TWIST DRILLGUIDE TWIST STOPPER DRILL 7 moreLINDEMANN DRILLPILOT DRILLPIN DRILLSTART DRILLSTOPPER PILOT DRILLSTOPPER TWIST DRILLTWIST DRILL | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ABIDING COUPLE DIGITAL LAB ANALOGABIDING COUPLE LAB ANALOGABIDING DIGITAL LAB ANALOG SCREWABIDING KITABIDING MU LAB ANALOGABIDING MU SCANBODYAF/EF COMPLETE KITAF/EF SNUCONE KITBONE TRIMMER GUIDE PINCOMPACT KIT 48 moreCOUPLE IMPRESSION COPING PICK-UPCOUPLE IMPRESSION COPING TRANSFERCOUPLE IMPRESSION PICK-UP SCREWCOUPLE IMPRESSION TRANSFER SCREWCRESTAL PREPARATORDEPTH GAUGE WRENCH GUIDE HOLDERDRILL EXTENSIONFIXTURE GRIP DRIVERFIXTURE GRIP WRENCH DRIVERFLAT DRIVERGINGIVA GAUGEGUIDE FIXTURE DRIVERGUIDE FIXTURE WRENCH DRIVERGUIDE MOUNTGUIDE PINGUIDE PIN (NON THREAD)GUIDE PIN (THREAD)GUIDE PIN CONNECTORGUIDE PIN SLEEVEGUIDE STENT SLEEVE NON THREADGUIDE STENT SLEEVE THREADGUIDE STENT SLEEVE WINDOWGUIDE STENT TRIMMERHANDPIECE HEX DRIVERHEX WRENCH DRIVERHYBRID PROSTHETIC KITMOUNT ADAPTOR (H/P)MOUNT ADAPTOR (T/W)MOUNT EXTENSIONMOUNT REMOVERO-RING DRIVERO-RING LAB ANALOGPARALLEL PINSCANBODYSCREW ABUTMENT DRIVERSLEEVE REMOVERSNUC ADVANCED GUIDED KITSNUC COMPACT GUIDED KITSNUC FULLY GUIDED KITSNUC NARROW GUIDED KITSNUC SOLE GUIDED KITSOLO IMPRESSION CAPSOLO LAB ANALOGSOLO PLASTIC COPINGTi SCANBODYTI SCANBODY SCREWTISSUE PUNCHTORQUE WRENCH | 2022 |
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 |
|---|---|---|
| SNUCONE CO., LTD.FDA reg. 3024858450 | Dalseo-gu Daegu, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086275). 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.