The following data is part of a premarket notification filed by Zest Anchors, Llc with the FDA for Saturno(tm) Overdenture Implant System.
| Device ID | K133327 |
| 510k Number | K133327 |
| Device Name: | SATURNO(TM) OVERDENTURE IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ZEST ANCHORS, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Contact | Linda Schulz |
| Correspondent | Linda Schulz ZEST ANCHORS, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-29 |
| Decision Date | 2014-06-25 |
| Summary: | summary |