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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 K153048
Device Name AcceleDent Aura
Applicant
Orthoaccel Technologies, Inc.
6575 W. Loop S., Suite 200
Bellaire,  TX  77401
Applicant Contact Zaffer Syed
Correspondent
Orthoaccel Technologies, Inc.
6575 W. Loop S., Suite 200
Bellaire,  TX  77401
Correspondent Contact Zaffer Syed
Regulation Number872.5470
Classification Product Code
OYH  
Date Received10/19/2015
Decision Date 07/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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