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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 K874025
Device Name 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN
Applicant
Astron Dental Corp.
280 Holdbrook Dr.
Wheeling,  IL  60090
Applicant Contact R. E MULLER
Correspondent
Astron Dental Corp.
280 Holdbrook Dr.
Wheeling,  IL  60090
Correspondent Contact R. E MULLER
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/02/1987
Decision Date 12/23/1987
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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