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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 East Easter Avenue #155
Centennial,  CO  80112
Applicant Contact Thomas Macari
Correspondent
QRS Solutions LLC
966 E. 2050 N
North 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
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