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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 K931870
Device Name BONDING RESIN PRODUCT LINE
Applicant
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Applicant Contact CHATWIN
Correspondent
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Correspondent Contact CHATWIN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/14/1993
Decision Date 07/22/1993
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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