The following data is part of a premarket notification filed by S-denti Co., Ltd. with the FDA for Navi Root.
| Device ID | K083901 |
| 510k Number | K083901 |
| Device Name: | NAVI ROOT |
| Classification | Locator, Root Apex |
| Applicant | S-DENTI CO., LTD. 5401 S COTTONWOOD CT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls S-DENTI CO., LTD. 5401 S COTTONWOOD CT Greenwood Village, CO 80121 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-04-15 |