The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Locator Implant Anchor Attachment System.
Device ID | K083324 |
510k Number | K083324 |
Device Name: | LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | ZEST ANCHORS, INC. 2061 WINERIDGE PL. Escondido, CA 92029 |
Contact | Richard A Overton |
Correspondent | Richard A Overton ZEST ANCHORS, INC. 2061 WINERIDGE PL. Escondido, CA 92029 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-12 |
Decision Date | 2009-02-25 |