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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 K122269
Model V80-**** AND VX80-****
Device Name ENAMIC
Original Applicant
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
3150 east birch street
brea,  CA  92821
Original Contact elizabeth wolfsen
Regulation Number872.6660
Classification Product Code
EIH  
Subsequent Product Code
EBF  
Date Received07/30/2012
Decision Date 12/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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