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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 K864757
Device Name MODIFIED VINYLAC PRESS PACK DENTURE RESIN
Applicant
Astron Dental Corp.
280 Holdbrook Dr.
Wheeling,  IL  60090
Applicant Contact ROBERT E MULLER
Correspondent
Astron Dental Corp.
280 Holdbrook Dr.
Wheeling,  IL  60090
Correspondent Contact ROBERT E MULLER
Regulation Number872.3760
Classification Product Code
EBI  
Date Received12/05/1986
Decision Date 02/10/1987
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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