The following data is part of a premarket notification filed by Zest Anchors, Llc with the FDA for Locator F-tx Attachment System.
| Device ID | K151789 |
| 510k Number | K151789 |
| Device Name: | LOCATOR F-Tx Attachment System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZEST ANCHORS, LLC 2061 WINERIDGE PLACE Escondido, CA 92029 |
| Contact | Annie Wright |
| Correspondent | Kevin A. Thomas PAXMED INTERNATIONAL, LLC 12264 EL CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-01 |
| Decision Date | 2016-03-04 |
| Summary: | summary |