510(k) K024214

KAVO EVEREST TITANBLANK by Kavo America — Product Code EJH

K024214 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO EVEREST TITANBLANK". The FDA issued a decision of Substantially Equivalent on March 12, 2003. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2003
Date Received
December 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type