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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 K220097
Device Name PRESIDENT The Original
Applicant
Coltène/Whaledent AG
Feldwiesenstrasse 20
Altstätten,  CH 9450
Applicant Contact Katrin Ader
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/12/2022
Decision Date 01/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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