The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Everest C-temp.
Device ID | K063624 |
510k Number | K063624 |
Device Name: | KAVO EVEREST C-TEMP |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | KAVO AMERICA PO BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm KAVO AMERICA PO BOX 7007 Deerfield, IL 60015 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-06 |
Decision Date | 2007-02-08 |
Summary: | summary |