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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 K132725
Device Name JUVORA DENTQAL DISC
Applicant
Juvora
Technology Centre
Hillhouse International
Thornton-Cleveleys, Lancashire,  GB FY5 4QD
Applicant Contact SELINA SHAW
Correspondent
Juvora
Technology Centre
Hillhouse International
Thornton-Cleveleys, Lancashire,  GB FY5 4QD
Correspondent Contact SELINA SHAW
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/30/2013
Decision Date 01/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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