The following data is part of a premarket notification filed by Zest Anchors, Llc with the FDA for Locator Overdenture Implant System.
Device ID | K120198 |
510k Number | K120198 |
Device Name: | LOCATOR OVERDENTURE IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | ZEST ANCHORS, LLC 2061 Wineridge Pl Escondido, CA 92029 |
Contact | Annie Wright |
Correspondent | Annie Wright ZEST ANCHORS, LLC 2061 Wineridge Pl Escondido, CA 92029 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-23 |
Decision Date | 2012-06-06 |
Summary: | summary |