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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K081084
Device Name COLORISE RIGID
Applicant
Zhermack S.P.A.
19379 Blue Lake Loop
Bend,  OR  97702
Applicant Contact GERALD W SHIPPS
Correspondent
Zhermack S.P.A.
19379 Blue Lake Loop
Bend,  OR  97702
Correspondent Contact GERALD W SHIPPS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/16/2008
Decision Date 05/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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