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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 K213093
Device Name STEP-1 PumEtch
Applicant
Rounding Third, LLC
9750 E. Easter Ave. #155
Centennial,  CO  80112
Applicant Contact Thomas Macari
Correspondent
Qrs Solutions, LLC
966 E. 2050 N
Ogden,  UT  84414
Correspondent Contact Adrienne Von Foller
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EJR  
Date Received09/24/2021
Decision Date 01/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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