510(k) K052130

VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 by Vident — Product Code EIH

K052130 is an FDA 510(k) premarket notification submitted by Vident for the device "VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40". The FDA issued a decision of Substantially Equivalent on August 15, 2005. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Vident has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
August 5, 2005
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