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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cement, Dental
510(k) Number K925713
Device Name VITA CEREC DUO CEMENT
Applicant
Vident
5130 Commerce Dr.
Baldwin Park,  CA  91706
Applicant Contact RAY E MORROW
Correspondent
Vident
5130 Commerce Dr.
Baldwin Park,  CA  91706
Correspondent Contact RAY E MORROW
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/12/1992
Decision Date 02/17/1993
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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