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510(k) K153048

Device
AcceleDent Aura
Applicant
ORTHOACCEL TECHNOLOGIES, INC.
510(k) number
K153048
Product code
OYH  
Decision
Substantially Equivalent (SESE)
Decision date
2016-07-08
Date received
2015-10-19
Regulation
872.5470
Classification name
Orthodontic Vibratory Accessory
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Zaffer Syed
Address
6575 W. Loop S., Suite 200 Bellaire TX US 77401 77401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OYH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183018VPro5Propel Orthodontics, LLC2019-11-01
K170093AcceleDent OptimaOrthoaccel Technology, Inc.2017-05-26
K130643ACCELEDENT AURAOrthoaccel Technologies, Inc.2013-04-23
K110661ACCELEDENTOrthoaccel Technologies, Inc.2011-11-17

Legacy Summary#

summary

FDA Review#

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