Data / Medical devices / South Korea / Hallim Point Implant Co., Ltd
Hallim Point Implant Co., Ltd: FDA-registered device maker in SIHEUNG-SI Gyeonggi, South Korea, 1 510(k) clearance
Hallim Point Implant Co., Ltd is registered with the FDA (registration 3005082946) in SIHEUNG-SI Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 25, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005082946
- Address
- 12, Mayu-ro, 92beon-gil, SIHEUNG-SI Gyeonggi, South Korea, --
- Owner or operator
- Hallim Point Implant Co., Ltd. (9071780)
- Roles
- Manufacturer
- First device listed
- March 28, 2005
- Registered through
- 2026
- Brand names listed
- ,, ARTE, CHALLENGE-EVER / HL-2060, HL2060A, DENTAL UNIT & CHAIR (CHALLENGE, ECLIPSE, ETC), GRASIA, GRASIA PLUS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2011 | K102223 | CHALLENGE-EVER | EIA | Substantially Equivalent | Hallim Dentech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 25, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.