FDA.reportPublic FDA data

510(k) K110661

Device
ACCELEDENT
Applicant
ORTHOACCEL TECHNOLOGIES, INC
510(k) number
K110661
Product code
OYH  
Decision
Substantially Equivalent (SESE)
Decision date
2011-11-17
Date received
2011-03-08
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
MICHAEL E KAUFMAN
Address
8275 El Rio, Suite 100 Houston TX US 77054 77054

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
K153048AcceleDent AuraOrthoaccel Technologies, Inc.2016-07-08
K130643ACCELEDENT AURAOrthoaccel Technologies, Inc.2013-04-23

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases