The following data is part of a premarket notification filed by Truabutment Inc. with the FDA for Uris Omni System.
| Device ID | K172100 |
| 510k Number | K172100 |
| Device Name: | URIS OMNI System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | TruAbutment Inc. 300 South Harbor Blvd #520 Anaheim, CA 92805 |
| Contact | Brandon Kim |
| 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 | 2017-07-11 |
| Decision Date | 2018-05-04 |
| Summary: | summary |