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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 City,  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
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