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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K052710
Device Name VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
Applicant
Vident
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact BARBARA J LEWANDOWSKI
Correspondent
Vident
3150 E. Birch St.
Brea,  CA  92821
Correspondent Contact BARBARA J LEWANDOWSKI
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/29/2005
Decision Date 01/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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