Manufacturer registered with FDA
Hallim Point Implant Co., Ltd.
SIHEUNG-SI, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Hallim Point Implant 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 | Hallim Point Implant Co., Ltd. | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | HALLIM POINT IMPLANT Co., Ltd. | 2 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | HALLIM POINT IMPLANT CO.,LTD | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | HALLIM POINT IMPLANT 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 Hallim Point Implant 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 |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | CHALLENGE-EVER / HL-2060, HL2060A | 2011 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | ARTEDENTAL UNIT & CHAIR (CHALLENGEECLIPSEETC)GRASIAGRASIA PLUS, | 2005 |
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
Hallim Point Implant 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: Hallim Dentech Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Feb 2011 | K102223 | CHALLENGE-EVER | Hallim Dentech Co., Ltd. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HALLIM POINT IMPLANT CO., LTDFDA reg. 3005082946 | SIHEUNG-SI Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9071780). 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.