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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 K912001
Device Name CONVERTRAY, MODIFICATION
Applicant
Wilde Dental (Usa)
C/O Robert W. Bauer & Assoc.
168 # Michigan Ave., Suite 800
Chicago,  IL  60602
Applicant Contact ROBERT W BAUER
Correspondent
Wilde Dental (Usa)
C/O Robert W. Bauer & Assoc.
168 # Michigan Ave., Suite 800
Chicago,  IL  60602
Correspondent Contact ROBERT W BAUER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/17/1991
Decision Date 01/09/1992
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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