Manufacturer registered with FDA
Evidence Implant Inc.
Daegu, South Korea. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name Evidence Implant Inc. 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 | Evidence Implant Inc. | 6 device types | — | Below |
| China | NMPA | Registration holder | 艾维丹斯种牙有限公司Evidence Implant Inc. | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Evidence Implant Inc. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Evidence Implant Inc. | 2 | 2025–2025 | 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 Evidence Implant Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Internal Hex Implant System | 2008 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Internal Hex Implant System | 2008 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | SD2207 SD2212 SD2214 SD2215 SD2807 SD2812 SD2814 SD2815 SD3507 SD3512 SD3514 SD3515 SD4215 | 2011 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | OPUMC35 OPUMC40 OPUMB35 OPUMB40 OPURC OPURB OFMM OFMR41 OFMR41b OFMW55 OFMW55b OFMMS OFMRS | 2011 |
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
Evidence Implant Inc. 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: Ebi, Inc. (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Jan 2020 | K190837 | Internal Hex Implant System | Ebi, Inc. | DZE Root-Form Endosseous Implant |
| 31 Aug 2017 | K170031 | Internal Octa Implant System | Ebi, Inc. | DZE Root-Form Endosseous Implant |
| 27 Mar 2015 | K142426 | EBI External Implant System | Ebi, Inc. | DZE Root-Form Endosseous Implant |
| 28 Feb 2008 | K073116 | EBI INTERNAL IMPLANT SYSTEM | Ebi, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Evidence Implant Inc.FDA reg. 3006592743 | Daegu, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024615). 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.