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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 K000597
Device Name VITA RESPONSE
Applicant
VIDENT
3150 EAST BIRCH ST.
BREA,  CA  92821
Applicant Contact BARBARA J LEWANDOWSKI
Correspondent
VIDENT
3150 EAST BIRCH ST.
BREA,  CA  92821
Correspondent Contact BARBARA J LEWANDOWSKI
Regulation Number872.6660
Classification Product Code
EIH  
Date Received02/22/2000
Decision Date 05/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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