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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Material, Impression
510(k) Number K955406
Device Name SCAN WHITE 12 ML
Applicant
Vident
3150 E. Birch St.
Brea,  CA  92821
Applicant Contact RAV E MORROW
Correspondent
Vident
3150 E. Birch St.
Brea,  CA  92821
Correspondent Contact RAV E MORROW
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/27/1995
Decision Date 12/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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