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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 Tray, Resin
510(k) Number K873739
Device Name ACRYLIC IMPRESSION TRAY MATERIALS
Applicant
E&D Dental Manufacturing Co.
6 Hoffman Place
Hillside,  NJ  07205
Applicant Contact ARTHUR SCHWARTZ
Correspondent
E&D Dental Manufacturing Co.
6 Hoffman Place
Hillside,  NJ  07205
Correspondent Contact ARTHUR SCHWARTZ
Regulation Number872.3670
Classification Product Code
EBH  
Date Received09/15/1987
Decision Date 03/07/1988
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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