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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K211813
Device Name Triton
Applicant
Inter-Med / Vista Dental
2200 S. St.
Racine,  WI  53404
Applicant Contact Brett Arand
Correspondent
Inter-Med / Vista Dental
2200 S. St.
Racine,  WI  53404
Correspondent Contact Brett Arand
Classification Product Code
KJJ  
Date Received06/11/2021
Decision Date 08/18/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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