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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 K940860
Device Name CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS
Applicant
Ultradent Products, Inc.
505 W. 10200 So.
South Jordan,  UT  84095
Applicant Contact F.M. HAVENGA
Correspondent
Ultradent Products, Inc.
505 W. 10200 So.
South Jordan,  UT  84095
Correspondent Contact F.M. HAVENGA
Regulation Number872.3660
Classification Product Code
ELW  
Date Received02/23/1994
Decision Date 05/27/1994
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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