The following data is part of a premarket notification filed by Zest Anchors, Llc with the FDA for Chairside Attachment Processing Material.
Device ID | K140570 |
510k Number | K140570 |
Device Name: | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | ZEST ANCHORS, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Contact | Allison C Komiyama |
Correspondent | Allison C Komiyama ZEST ANCHORS, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-06 |
Decision Date | 2014-06-16 |
Summary: | summary |