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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 K000983
Device Name CERAMIX PORCELAIN SYSTEM
Applicant
C-Mix
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ART WARD
Correspondent
C-Mix
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ART WARD
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/27/2000
Decision Date 08/26/2000
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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