Data / Medical devices / South Korea / Evidence Implant Inc.
Evidence Implant Inc.: FDA-registered device maker in Daegu, South Korea, 4 510(k) clearances
Evidence Implant Inc. is registered with the FDA (registration 3006592743) in Daegu, South Korea. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 22, 2020. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006592743
- Address
- 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea, Daegu, South Korea, 41065
- Owner or operator
- Evidence Implant Inc. (10024615)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 15, 2008
- Registered through
- 2027
- Brand names listed
- Internal Hex Implant System, OPUMC35 OPUMC40 OPUMB35 OPUMB40 OPURC OPURB OFMM OFMR41 OFMR41b OFMW55 OFMW55b OFMMS OFMRS, SD2207 SD2212 SD2214 SD2215 SD2807 SD2812 SD2814 SD2815 SD3507 SD3512 SD3514 SD3515 SD4215
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| January 22, 2020 | K190837 | Internal Hex Implant System | DZE | Substantially Equivalent | Ebi, Inc. | accessdata.fda.gov |
| August 31, 2017 | K170031 | Internal Octa Implant System | DZE | Substantially Equivalent | Ebi, Inc. | accessdata.fda.gov |
| March 27, 2015 | K142426 | EBI External Implant System | DZE | Substantially Equivalent | Ebi, Inc. | accessdata.fda.gov |
| February 28, 2008 | K073116 | EBI INTERNAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Ebi, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Elevator, Surgical, Dental
- All makers of Handle, Instrument, Dental
- All makers of Bur, Dental
- All makers of Accessories, Implant, Dental, Endosseous
Updated January 22, 2020. 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.