510(k) K130643

Device: ACCELEDENT AURA
Applicant: ORTHOACCEL TECHNOLOGIES, INC
510(k) number: K130643
Product code: OYH
Decision: Substantially Equivalent (SESE)
Decision date: 2013-04-23
Date received: 2013-03-11
Regulation: 872.5470
Classification name: Orthodontic Vibratory Accessory
Medical specialty: Dental
Review panel: Dental
Device class: 2
Clearance type: Special
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#

2424472
2950160
3013423303

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00865515000200	AcceleDent	ORTHOACCEL TECHNOLOGIES, INC.	2016-09-06

Other 510(k) Records For Product Code OYH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K183018	VPro5	Propel Orthodontics, LLC	2019-11-01
K170093	AcceleDent Optima	Orthoaccel Technology, Inc.	2017-05-26
K153048	AcceleDent Aura	Orthoaccel Technologies, Inc.	2016-07-08
K110661	ACCELEDENT	Orthoaccel Technologies, Inc.	2011-11-17

Legacy Summary#

summary

FDA Review#

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