Data / Medical devices / South Korea / Eclectic Inc.
Eclectic Inc.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 2 510(k) clearances
Eclectic Inc. is registered with the FDA (registration 3029820793) in Hwaseong-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029820793
- Address
- 33, Buncheon-gil 45beon-gil Bongdam-eup, Hyohaeng-gu, Hwaseong-si Gyeonggi, South Korea, 18329
- Owner or operator
- ECLECTIC INC. (10091703)
- Roles
- Manufacturer
- First device listed
- October 25, 2024
- Registered through
- 2026
- Brand names listed
- Anchor Drill 1.35mm ACD 13, Bone Expander 2.80mm BEX 28, Bone Expander 3.40mm BEX 34, Bone Expander 3.90mm BEX 39, Bone Expander 4.30mm BEX 43, Bone Profile Drill 4.60mm GBD 46, Bone Profile Drill 50mm Wide Sleeve GBD 50W, Cortical Drill 4.25mm CTD 42 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| October 18, 2024 | K240725 | PreXolid CAD/CAM abutments | NHA | Substantially Equivalent | Eclectic Co., Ltd. | accessdata.fda.gov |
| May 24, 2024 | K231426 | 8plant Implant System | DZE | Substantially Equivalent | Hoowon Edi Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated October 18, 2024. 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.