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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reliner, denture, over the counter
510(k) Number K121318
Device Name PROSOFT
Original Applicant
120 wakefield run blvd
hinckley,  OH  44233
Regulation Number872.3560
Classification Product Code
Date Received05/02/2012
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No