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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 K170093
Device Name AcceleDent Optima
Applicant
OrthoAccel Technology Inc.
6575 West Loop South, Suite 200
Bellaire,  TX  77401
Applicant Contact Jouana Harris-Livings
Correspondent
OrthoAccel Technology Inc.
6575 West Loop South, Suite 200
Bellaire,  TX  77401
Correspondent Contact Jouana Harris-Livings
Regulation Number872.5470
Classification Product Code
OYH  
Date Received01/11/2017
Decision Date 05/26/2017
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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