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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 K153191
Device Name Calcium Bridge
Applicant
Denali Corporation
134 Old Washington St.
Hanover,  MA  02339
Applicant Contact Jan G Stannard
Correspondent
Denali Corporation
134 Old Washington St.
Hanover,  MA  02339
Correspondent Contact Jan G Stannard
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/03/2015
Decision Date 02/26/2016
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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