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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord, retraction
510(k) Number K152064
Device Name Astringedent Clear
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Applicant Contact COREY JASEPH
Correspondent
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Correspondent Contact COREY JASEPH
Classification Product Code
MVL  
Date Received07/24/2015
Decision Date 09/24/2015
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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