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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 K101771
Device Name RELINE-IT MODEL RELINE-IT
Applicant
Majestic Drug Co., Inc.
848-1/2 Derby Ave.
Orange,  CT  06477
Applicant Contact ROGER S MASTRONY
Correspondent
Majestic Drug Co., Inc.
848-1/2 Derby Ave.
Orange,  CT  06477
Correspondent Contact ROGER S MASTRONY
Regulation Number872.3560
Classification Product Code
EBP  
Date Received06/24/2010
Decision Date 09/20/2010
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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