Manufacturer registered with FDA
ACH Medical Co., Ltd.
Hwaseong-si, South Korea. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 68
- 510(k) clearances
- 0as applicant
- Markets registered in
- 612 registrations outside the US
- Establishments
- 1South Korea
Registered in 6 markets
Where regulators' registries name ACH Medical 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 | ACH Medical Co., Ltd. | 8 device types | — | Below |
| Taiwan | TFDA | Manufacturer | ACH Medical Co., Ltd. | 5 | 2013–2021 | Pure Global AI |
| China | NMPA | Registration holder | 爱绮医疗器材ACH Medical Co., Ltd. | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ACH MEDICAL Co., Ltd. | 2 | 2022–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ACH MEDICAL CO., LTD. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | ACH Medical 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 ACH Medical 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 | AIMGENBiogenesis Implant System - AticonBiogenesis Implant System - KissesIBIB MiniIB-TKisses Mini Implant SystemKisses Plus Implant SystemNexplantZenex Abutment 6 moreZenex Blue AbutmentZenex FixtureZenex Implant FixtureZenex Micro Thread FixtureZenex MiniZenex Pink Abutment | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | AIMGENBiogenesis Implant System - AticonBiogenesis Implant System - KissesIBIB MiniIB-TKisses Mini Implant SystemKisses Plus Implant SystemNexplantZenex Abutment 6 moreZenex Blue AbutmentZenex FixtureZenex Implant FixtureZenex Micro Thread FixtureZenex MiniZenex Pink Abutment | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Cortical drillDiamond Lindermann drillPilot drillSidecut drillStep drillStraight drillTwist drill | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Abutment lab analogBall lab analogFixture lab analogImpression copin guide pinPick-up impression copingPlastic impression copingTransfer impression coping | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Diamond 3D drillDiamond Ossteotomy drill | 2013 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Maker | Serrated Curette | 2013 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | Socket Bone File | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bone collectorBone collector extractorBone collector stopperConnector pinDepth pinDrill extensionDrill stopperHandpiece connectorHex driverMachine screw driver 8 moreMount holdOcta driverParallel pinProtect capRatchet adaptorRatchet wrenchSolid driverTorque wrench | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
ACH Medical Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Achimhai Medical Corporation (3), Biogenesis Co., Ltd. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 6 Aug 2021 | K200193 | Kisses Plus Implant System | Achimhai Medical Corporation | NHA Endosseous Dental Implant Abutment |
| 3 Apr 2018 | K172630 | Kisses Plus Implant System | Achimhai Medical Corporation | DZE Root-Form Endosseous Implant |
| 6 Oct 2017 | K170394 | Kisses Mini | Achimhai Medical Corporation | DZE Root-Form Endosseous Implant |
| 31 Jul 2015 | K142813 | Biogensis Implant System-Kisses | Biogenesis Co., Ltd. | DZE Root-Form Endosseous Implant |
| 13 Mar 2013 | K120089 | BIOGENESIS IMPLANT SYSTEM | Biogenesis Co., Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ACH Medical Co., Ltd.FDA reg. 3009848796 | Hwaseong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043821). 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.