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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K011706
Device Name FLEXICAST PRIME
Applicant
American Dent-All, Inc.
5140 San Fernando Rd.
Glendale,  CA  91204
Applicant Contact VACHAKAN H KHOIE
Correspondent
American Dent-All, Inc.
5140 San Fernando Rd.
Glendale,  CA  91204
Correspondent Contact VACHAKAN H KHOIE
Regulation Number872.3710
Classification Product Code
EJH  
Date Received06/04/2001
Decision Date 08/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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