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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800076400795 | K172100 | 000 |
| 08800076400214 | K172100 | 000 |
| 08800076400207 | K172100 | 000 |
| 08800076400191 | K172100 | 000 |
| 08800076400184 | K172100 | 000 |
| 08800076400177 | K172100 | 000 |
| 08800076400160 | K172100 | 000 |
| 08800076400153 | K172100 | 000 |
| 08800076400146 | K172100 | 000 |
| 08800076400139 | K172100 | 000 |
| 08800076400122 | K172100 | 000 |
| 08800076400115 | K172100 | 000 |
| 08800076400108 | K172100 | 000 |
| 08800076400092 | K172100 | 000 |
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| 08800076400061 | K172100 | 000 |
| 08800076400221 | K172100 | 000 |
| 08800076400238 | K172100 | 000 |
| 08800076400399 | K172100 | 000 |
| 08800076400382 | K172100 | 000 |
| 08800076400375 | K172100 | 000 |
| 08800076400368 | K172100 | 000 |
| 08800076400351 | K172100 | 000 |
| 08800076400344 | K172100 | 000 |
| 08800076400337 | K172100 | 000 |
| 08800076400320 | K172100 | 000 |
| 08800076400313 | K172100 | 000 |
| 08800076400306 | K172100 | 000 |
| 08800076400290 | K172100 | 000 |
| 08800076400283 | K172100 | 000 |
| 08800076400276 | K172100 | 000 |
| 08800076400269 | K172100 | 000 |
| 08800076400252 | K172100 | 000 |
| 08800076400245 | K172100 | 000 |
| 08800076400054 | K172100 | 000 |