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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K171576
Device Name The Panthera Anti-Snoring X3 Device
Applicant
Panthera Dental Inc.
2035, rue du Haut-Bord
Quebec city,  CA G1N 4N7
Applicant Contact Martine Fortin
Correspondent
Panthera Dental Inc.
2035, rue du Haut-Bord
Quebec city,  CA G1N 4N7
Correspondent Contact Martine Fortin
Regulation Number872.5570
Classification Product Code
LRK  
Date Received05/30/2017
Decision Date 02/22/2018
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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