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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 K000680
Device Name VISION ESTHETIC PORCELAIN SYSTEM
Applicant
MIDATLANTIC DIVISION OF DENTREX, INC.
600 DEER RD.
SUITE 3
CHERRY HILL,  NJ  08034
Applicant Contact LAURANCE W POWELL
Correspondent
MIDATLANTIC DIVISION OF DENTREX, INC.
600 DEER RD.
SUITE 3
CHERRY HILL,  NJ  08034
Correspondent Contact LAURANCE W POWELL
Regulation Number872.6660
Classification Product Code
EIH  
Date Received02/29/2000
Decision Date 05/25/2000
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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