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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K854957
Device Name AUSTENAL DENTAL COMPOSITE RESIN
Applicant
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact ROGER MOLA
Correspondent
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact ROGER MOLA
Regulation Number872.3310
Classification Product Code
EBD  
Date Received12/11/1985
Decision Date 01/30/1986
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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