The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Zest Implant Anchor.
Device ID | K925849 |
510k Number | K925849 |
Device Name: | ZEST IMPLANT ANCHOR |
Classification | Implant, Endosseous, Root-form |
Applicant | ZEST ANCHORS, INC. 2000 M STREET, N.W. SUITE 700 Washington, DC 20036 |
Contact | Daniel J Manelli |
Correspondent | Daniel J Manelli ZEST ANCHORS, INC. 2000 M STREET, N.W. SUITE 700 Washington, DC 20036 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-18 |
Decision Date | 1994-11-18 |