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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 K100794
Device Name FLUORCANASITE DENTAL CERAMIC
Applicant
Dr Sarah Pollington
3010 Lbj Frwy., 12th Floor
Dallas,  TX  75234
Applicant Contact JUDY BURTON
Correspondent
Dr Sarah Pollington
3010 Lbj Frwy., 12th Floor
Dallas,  TX  75234
Correspondent Contact JUDY BURTON
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/22/2010
Decision Date 01/25/2011
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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