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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K192108
Device Name Panthera Dental Milled Bars
Applicant
Panthera Dental, Inc.
2035 Rue Du Haut-Bord
Quebec City,  CA G1n 4N7
Applicant Contact Martine Fortin
Correspondent
Panthera Dental, Inc.
9105, Rue John-Simons
Quebec,  CA G2B 0S6
Correspondent Contact Martine Fortin
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/05/2019
Decision Date 04/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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