The following data is part of a premarket notification filed by Ivory Super Holdco, Incp. with the FDA for Locator R-tx.
| Device ID | K200827 |
| 510k Number | K200827 |
| Device Name: | LOCATOR R-Tx |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Ivory Super Holdco, Incp. 2875 Locker Ave East Carlsbad, CA 92010 |
| Contact | Marysa Loustalot |
| Correspondent | Marysa Loustalot Ivory Super Holdco, Incp. 2875 Locker Ave East Carlsbad, CA 92010 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-30 |
| Decision Date | 2020-09-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LOCATOR R-TX 86824880 5101791 Live/Registered |
Zest IP Holdings, LLC 2015-11-18 |