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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K913089
Device Name WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS
Applicant
Wilde-USA, Inc.
P.O. Box 4168
Naperville,  IL  60567
Applicant Contact ROBERT W BAUER
Correspondent
Wilde-USA, Inc.
P.O. Box 4168
Naperville,  IL  60567
Correspondent Contact ROBERT W BAUER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/12/1991
Decision Date 04/21/1992
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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