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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K896785
Device Name ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/
Applicant
Craft Dental Laboratory, Inc.
1583 W. Forest Home Ave.
Milwaukee,  WI  53204
Applicant Contact DALE B PARASK
Correspondent
Craft Dental Laboratory, Inc.
1583 W. Forest Home Ave.
Milwaukee,  WI  53204
Correspondent Contact DALE B PARASK
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/04/1989
Decision Date 04/19/1990
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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