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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 K060086
Device Name FENIIIIIIX COLORATION KIT
Applicant
Dental Arte, Inc.
12315 Oak Knoll Rd.
Suite 330
Poway,  CA  92064 -5343
Applicant Contact MASSIMO SASSO
Correspondent
Dental Arte, Inc.
12315 Oak Knoll Rd.
Suite 330
Poway,  CA  92064 -5343
Correspondent Contact MASSIMO SASSO
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/11/2006
Decision Date 03/03/2006
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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