The following data is part of a premarket notification filed by Ebi, Inc. with the FDA for Ebi Internal Implant System.
| Device ID | K073116 |
| 510k Number | K073116 |
| Device Name: | EBI INTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | EBI, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm EBI, INC. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-05 |
| Decision Date | 2008-02-28 |
| Summary: | summary |