Manufacturer registered with FDA
PointImplant Co Ltd
Busan, South Korea. Lists 5 dental device types with FDA across 2 registered establishments.
- Device types listed
- 5
- Brands and models
- 82
- 510(k) clearances
- 0as applicant
- Markets registered in
- 721 registrations outside the US
- Establishments
- 2South Korea
Registered in 7 markets
Where regulators' registries name PointImplant 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 | PointImplant Co Ltd | 5 device types | — | Below |
| Taiwan | TFDA | Manufacturer | POINTIMPLANT Co., LtdPOINTIMPLANT Co., Ltd. · POINT IMPLANT Co., Ltd. | 8 | 2010–2025 | Pure Global AI |
| China | NMPA | Registration holder | 盘泰医疗器械有限公司POINTIMPLANT Co., Ltd.盘泰医疗器械有限公司POINTIMPLANT Co., Ltd · 盘泰医疗器械有限公司POINTIMPLANT Co.,Ltd. | 5 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | POINTIMPLANT Co., Ltd. | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Point Implant Co., Ltd. | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＰＯＩＮＴＩＭＰＬＡＮＴ Ｃｏ．， Ｌｔｄ． | 1 | 2019–2019 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | POINTIMPLANT Co., Ltd. | 1 | 2022–2022 | 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 PointImplant 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Bone Profile DrillCortical DrillFinal DrillFixture Tap DrillInitial DrillLance DrillPoint DrillSideCut DrillTissue Punch Drill | 2021 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment ScrewAngled AbutmentCemented AbutmentCover ScrewFixture MountFixture Mount ScrewHealing AbutmentSM II FixtureSolid AbutmentSolid Cap 1 moreTemporary Abutment | 2023 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | — | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Removal TipBall Abutment DriverBall AnalogBite Impression CopingBite Impression Coping CapBite Scan BodyBITE-KITDepth GageDigital Lab AnalogDrill Extension 41 moreDrill TubeExcellent Solid AnalogFixture analogFixture DriverFixture MountFixture Mount ScrewFixture pinGuide pinHand DriverImpression Coping DriverLab analogMachine Screw DriverMount DriverMount ExtensionMount Open WrenchMulti Abutment CarrierMulti Abutment DriverMulti Guide PinMulti Impression CopingNAVI-KITNo-Mount DriverOT-KITOTA-KITOTS-KITParallel PinPick-Up Impression CopingPincettePlastic SleevePRO-KITRatchet WrenchRemove DriverScan BodyScan Body ScrewSlot DriverSolid DriverStopperTorque DriverTorque ExtensionTorque WrenchTransfer Impression copingVertical Anchor | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment ScrewAngled AbutmentCemented AbutmentCover ScrewFixture MountFixture Mount ScrewHealing AbutmentSM II FixtureSolid AbutmentSolid Cap 1 moreTemporary Abutment | 2023 |
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
PointImplant 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: Pointnix Co., Ltd. (1), Pointnix Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Apr 2023 | K222738 | Point implant system | Pointnix Co., Ltd. | DZE Root-Form Endosseous Implant |
| 24 Jan 2013 | K121800 | POINT 500 HD POINT500C HD | Pointnix Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| POINTIMPLANT Co., LtdFDA reg. 3011891801 | Busan, South Korea | Complaint file establishment, Manufacturer |
| POINTIMPLANT CO., LTD.FDA reg. 3010476612 | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083213, 10045396). 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.