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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K844349
Device Name SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS
Applicant
Ivoclar USA, Inc.
Bauer, Cheng & Associates
111 N. Wabash
Chicago,  IL  60602
Applicant Contact ROBERT W BAUER
Correspondent
Ivoclar USA, Inc.
Bauer, Cheng & Associates
111 N. Wabash
Chicago,  IL  60602
Correspondent Contact ROBERT W BAUER
Regulation Number872.3590
Classification Product Code
ELM  
Date Received11/09/1984
Decision Date 12/03/1984
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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