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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 K052130
Device Name VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
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 Received08/05/2005
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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