Manufacturer registered with FDA
CSM Implant
Daegu, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 50
- 510(k) clearances
- 42011–2018
- Markets registered in
- 517 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name CSM Implant 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 | CSM Implant | 4 clearances | 2011–2018 | Below |
| Taiwan | TFDA | Manufacturer | CSM IMPLANTCSM IMPLANT CO. · CSM Implant | 8 | 2008–2023 | Pure Global AI |
| China | NMPA | Registration holder | 熙直美CSM Implant诺熙斯CSM Implant | 6 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | CSM Implant | 2 | 2013–2016 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CSM Implant | 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 CSM Implant 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 | CSM Submerged3-L Implant Systemimplant1implant2implant3 | 2011 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CSM Submerged3-L Implant Systemimplant1implant2 | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bone CarrierBone CondenserCountersinkDepth GaugeDrill ExtensionDummyFixture AnalogueFixture Remover DriverGuide DrillGuide Driver 33 moreGuide Driver HolderGuide HolderGuide PinI-DrillI-Drill StopperImpression Coping (Pick-up, Transfer)Impression Coping Pin (Pick-up)Lindman DrillMount DriverMountless DriverOcta Abutment AnalogueOcta Abutment Impression Coping (Pick-up, Transfer)Octa Abutment Impression Coping PinOcta DriverReamerRemover DrillRemover ScrewRetainer DriverRetainer Impression Plastic MaleRetainer Impression SpaceRound BurSolid DriverSpreader DriverStopperStopper (Small, Big)Stopper StandTapTissue PunchTorque WrenchTorx DriverTrephine DrillTwist DrillWrench Adapter | 2006 |
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 CSM Implant as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Sep 2018 | K173141 | CSM Submerged3-L Implant System | DZE Root-Form Endosseous Implant |
| 27 Apr 2012 | K120043 | CSM INTERNAL-R IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 14 Oct 2011 | K111120 | CSM SUBMERGED-R IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Mar 2011 | K102635 | APOLONIA LASER IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CSM ImplantFDA reg. 3005998060 | DAEGU, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9090832). 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.