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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 K884865
Device Name PERMASEAL AND DENTURE SEAL
Applicant
American Mfg., Inc.
10500 Glenhaven Dr.
Silver Spring,  MD  20902
Applicant Contact J DORSIE
Correspondent
American Mfg., Inc.
10500 Glenhaven Dr.
Silver Spring,  MD  20902
Correspondent Contact J DORSIE
Regulation Number872.3760
Classification Product Code
EBI  
Date Received11/22/1988
Decision Date 01/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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