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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name resin, denture, relining, repairing, rebasing
510(k) Number K140570
Device Name CHAIRSIDE ATTACHMENT PROCESSING MATERIAL
Applicant
ZEST ANCHORS, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Applicant Contact allison c komiyama
Correspondent
ZEST ANCHORS, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact allison c komiyama
Regulation Number872.3760
Classification Product Code
EBI  
Date Received03/06/2014
Decision Date 06/16/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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