The following data is part of a premarket notification filed by Ebi Inc. with the FDA for Internal Octa Implant System.
| Device ID | K170031 |
| 510k Number | K170031 |
| Device Name: | Internal Octa Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | EBI Inc. 124, Uisong-gil, Amnyang-myeon Gyeongsan-si, KR 38493 |
| Contact | Mi Sook Kim |
| Correspondent | April Lee Withus Group Inc 2531 Pepperdale Drive Rowland Heights, CA 91748 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-04 |
| Decision Date | 2017-08-31 |
| Summary: | summary |