510(k) K032081

KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 by Kavo America — Product Code EIH

K032081 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60". The FDA issued a decision of Substantially Equivalent on July 24, 2003. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Kavo America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2003
Date Received
July 7, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type