The following data is part of a premarket notification filed by Ebi Inc. with the FDA for Internal Hex Implant System.
| Device ID | K190837 |
| 510k Number | K190837 |
| Device Name: | Internal Hex Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | EBI Inc. 124, Uisong-gil, Amnyang-myeon Gyeongsan-si, KR 38493 |
| Contact | Dongjun Yang |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2020-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809486111062 | K190837 | 000 |