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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 K921602
Device Name ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT
Applicant
Ultradent Products, Inc.
1345 E. 3900 So.
Salt Lake City,  UT  84124
Applicant Contact LINDA CHATWIN
Correspondent
Ultradent Products, Inc.
1345 E. 3900 So.
Salt Lake City,  UT  84124
Correspondent Contact LINDA CHATWIN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/03/1992
Decision Date 09/09/1992
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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