510(k) K063624

KAVO EVEREST C-TEMP by Kavo America — Product Code EBG

K063624 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO EVEREST C-TEMP". The FDA issued a decision of Substantially Equivalent on February 8, 2007. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2007
Date Received
December 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type