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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 K060860
Device Name TURKOM-CERA
Applicant
Dental Suppliers of America, Inc.
18616 123rd. Ave. NE
Arlington,  WA  98223
Applicant Contact DAN WATSON
Correspondent
Dental Suppliers of America, Inc.
18616 123rd. Ave. NE
Arlington,  WA  98223
Correspondent Contact DAN WATSON
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/29/2006
Decision Date 05/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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