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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 K130643
Device Name ACCELEDENT AURA
Applicant
ORTHOACCEL TECHNOLOGIES, INC
6575 WEST LOOP SOUTH, STE 200
BELLAIRE,  TX  77401
Applicant Contact ZAFFER SYED
Correspondent
ORTHOACCEL TECHNOLOGIES, INC
6575 WEST LOOP SOUTH, STE 200
BELLAIRE,  TX  77401
Correspondent Contact ZAFFER SYED
Regulation Number872.5470
Classification Product Code
OYH  
Date Received03/11/2013
Decision Date 04/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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