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 |