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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Vibratory Accessory
510(k) Number K183018
Device Name VPro5
Applicant
Propel Orthodontics LLC
394 South Abbott Ave
Milpitas,  CA  95035
Applicant Contact Bryce Way
Correspondent
Propel Orthodontics LLC
394 South Abbott Ave
Milpitas,  CA  95035
Correspondent Contact Bryce Way
Regulation Number872.5470
Classification Product Code
OYH  
Date Received10/31/2018
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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