The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Bioceram Zest Plant.
Device ID | K840244 |
510k Number | K840244 |
Device Name: | BIOCERAM ZEST PLANT |
Classification | Implant, Endosseous, Root-form |
Applicant | ZEST ANCHORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-20 |
Decision Date | 1984-05-01 |