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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K913581
Device Name WILDE ADHESIVE BONDING SYSTEM
Applicant
WILDE-USA, INC.
1819 SO. MAY ST.
UNIT 2F
CHICAGO,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
WILDE-USA, INC.
1819 SO. MAY ST.
UNIT 2F
CHICAGO,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/12/1991
Decision Date 02/26/1993
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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