Manufacturer registered with FDA
Cybermed Inc.
Daejeon, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 160
- 510(k) clearances
- 12022–2022
- Markets registered in
- 815 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Cybermed Inc. 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 | Cybermed Inc. | 1 clearances | 2022–2022 | Below |
| European Union | EUDAMED | Manufacturer | Cybermed Inc., | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CYBERMED INC.CyberMed Inc. | 4 | 2012–2022 | Pure Global AI |
| Japan | PMDA | Registration holder | ＣｙｂｅｒＭｅｄ Ｉｎｃ． | 2 | 2016–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | CyberMed Inc | 1 | 2018–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CYBERMED, INC. | 1 | 2019–2019 | Pure Global AI |
| Canada | Health Canada | Registration holder | CYBERMED, INC. | 1 | 2012–2012 | Pure Global AI |
| China | NMPA | Registration holder | 赛博美德有限公司Cybermed, Inc. | 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 Cybermed Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | ABT. ProfilerAnchor DrillBone FlatterBone ProfilerConnecter-handpieceConnector-RachetCORE D Guide KITCORE DrillCORE Master KITCORE Master KIT (Mini & Short) 39 moreCORE Master KIT (Mini)CORE Master KIT (Short)CORE Master KIT FullCORE Master KIT SimpleCORE Sinus KITCORE Sinus Master KITCORE Universal Guide KITCORE Universal Remover and Prosthetic KITCORE Z Guide KITCORE1 Guide KITCORE1 Guide KIT SimpleCortical DrillCrestal Guide DrillCS DrillCS First DrillFirst DrillGuide DrillGuided DrillIn2Guide Surgical TemplateIn2Guide Universal KitInitial DrillInitial Guide DrillLateral DrillLateral Guide DrillLS Carbide BurLS Diamond BurMount(AOS)Osteoplasty BurPoint DrillReborn Guide KITReborn Master KITReborn Master KIT FullReborn Sinus KITReborn Sinus Master KITReborn Universal Guide KITRemover DrillReverse DrillT.A DrillTap Drill | 2009 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | CORE1 Implant SystemREBORN ImplantSystem | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Screw DriverAnchor PinAnchor SleeveBase Metal CarrierBone CarrierBone FlatterBone PackerBone ProfilerBone PusherC Sleeve 97 moreCORE Implant MountCORE Master KITCORE Master KIT (Mini & Short)CORE Master KIT (Mini)CORE Master KIT (Short)CORE Master KIT FullCORE Master KIT SimpleCORE Mount DriverCORE Mount ExtensionCORE Sinus KITCORE Sinus Master KITCORE Universal Guide KITCORE Universal Remover and Prosthetic KITCORE1 Guide KITCORE1 Guide KIT SimpleCORE1 Implant MountCORE1 Implant Mount ExtensionCORE1 Mount DriverCORE1 Prosthetic KITCrestal Stoppercurette1curette2Depth GaugeDepth Gauge & ProbeDepth Gauge & Sinus CuretteDigital Lab AnalogDrill ExtensionDrill GuideDrill HandleDrill StopperDriver ExtensionER ToolF.A DriverFixing AnchorFixture DriverFixture Remover ScrewFlat Tip DriverFunnelGuide HolderHandpiece CondenserHAS Scan BodyHAS Scan Body CarrierHydro Membrane LifterHydro Membrane Lifter TubeImplant DriverImpression capLab AnalogLateral Wall ExpanderMembrane LifterMembrane SeparatorO SleeveOsteoplasty BurParallel PinPath PinPick-up impression copingPick-up impression coping guide pinProbeRatchet ExtensionReborn Guide KITReborn Master KITReborn Master KIT FullReborn Prosthetic KITReborn Sinus KITReborn Sinus Master KITReborn Universal Guide KITScan BodyScan Body CarrierScan Body Carrier ScrewScan Body ScrewScan CapSCS DriverSolid Lab AnalogStopperTemplate AnchorTissue PunchTorque WrenchTransfer impression copingTransfer impression coping guide pinTurning HandleUnigrip DriverUniversal Healing CapUniversal Impression Cap (Pick-up)Universal Impression Cap (Transfer)Universal Lab AnalogUniversal Metal CarrierUniversal Outer DriverUniversal Plastic CarrierUniversal Temporary CylinderUniversal Ti CylinderWrench - LongWrench Condenser0.5 Slot Driver0.9 Hex Driver1.2 Angled Driver1.2 Hex Driver1.25 Angled Driver1.25 Hex Driver | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CORE1 Implant SystemREBORN ImplantSystem | 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 |
|---|---|---|
| Cybermed Inc.FDA reg. 3003781339 | Daejeon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9048516). 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.