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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 K111178
Device Name JUELL SOFT CURE
Original Applicant
JUELL DENTAL
2401 n commerce
ardmore,  OK  73401
Original Contact angela blackwell
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/27/2011
Decision Date 09/12/2011
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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