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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K051931
Device Name AXCEL
Applicant
Tri Dental Innovators
13902 W. St., Unit C
Garden Grove,  CA  92843
Applicant Contact LINDA NGUYEN
Correspondent
Tri Dental Innovators
13902 W. St., Unit C
Garden Grove,  CA  92843
Correspondent Contact LINDA NGUYEN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/13/2005
Decision Date 02/17/2006
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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