Data / Medical devices / South Korea / POINTIMPLANT Co., Ltd
POINTIMPLANT Co., Ltd: FDA-registered device maker in Busan, South Korea, 1 510(k) clearance
POINTIMPLANT Co., Ltd is registered with the FDA (registration 3011891801) in Busan, South Korea. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 13, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011891801
- Address
- B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, South Korea, 46509
- Owner or operator
- PointImplant Co Ltd (10083213)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 3, 2021
- Registered through
- 2027
- Brand names listed
- Abutment Removal Tip, Abutment Screw, Angled Abutment, BITE-KIT, Ball Abutment Driver, Ball Analog, Bite Impression Coping, Bite Impression Coping Cap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 13, 2023 | K222738 | Point implant system | DZE | Substantially Equivalent | Pointnix Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Dental, Intraoral
Updated April 13, 2023. 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.