510(k) K060441

VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 by Vident — Product Code EIH

K060441 is an FDA 510(k) premarket notification submitted by Vident for the device "VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98". The FDA issued a decision of Substantially Equivalent on April 27, 2006. 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
April 27, 2006
Date Received
February 21, 2006
Clearance Type
Traditional
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