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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 K182296
Device Name HyperFil-LV
Applicant
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Applicant Contact David Mott
Correspondent
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Correspondent Contact David Mott
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/24/2018
Decision Date 12/14/2018
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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