The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Locator Rtx.
| Device ID | K150295 |
| 510k Number | K150295 |
| Device Name: | LOCATOR RTx |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ZEST ANCHORS, INC. 2061 WINERIDGE PL. Escondido, CA 92029 |
| Contact | Annie Wrigth |
| Correspondent | Linda K Schulz 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 | 2015-02-06 |
| Decision Date | 2015-07-24 |
| Summary: | summary |