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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 K863421
Device Name SR-IVOLEN TRAY MATERIAL
Applicant
Ivoclar USA, Inc.
Bauer, Cheng & Associates
111 N. Wabash
Chicago,  IL  60602
Applicant Contact BAUER, PHD
Correspondent
Ivoclar USA, Inc.
Bauer, Cheng & Associates
111 N. Wabash
Chicago,  IL  60602
Correspondent Contact BAUER, PHD
Regulation Number872.3670
Classification Product Code
EBH  
Date Received09/04/1986
Decision Date 11/03/1986
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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