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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 K160918
Device Name JUVORA Dental Disc, Ceramill PEEK by JUVORA
Applicant
JUVORA
TECHNOLOGY CENTRE, HILLHOUSE INTERNATIONAL
THORNTON-CLEVELEYS,  GB FY5 4QD
Applicant Contact SELINA SALTHOUSE
Correspondent
JUVORA
TECHNOLOGY CENTRE, HILLHOUSE INTERNATIONAL
THORNTON-CLEVELEYS,  GB FY5 4QD
Correspondent Contact TIM LEYVA
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBF   EBG  
Date Received04/04/2016
Decision Date 02/13/2017
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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