Home GUDID 00865515000217 AcceleDent
Primary DI 00865515000217
Brand AcceleDent
Company ORTHOACCEL TECHNOLOGIES, INC.
Model Optima
Device description Accelerated Orthodontic Treatment
Published 2017-06-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OYH Orthodontic Vibratory Accessory
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OYH Orthodontic Vibratory Accessory Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00865515000217 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00865515000217 00865515000217 865515000217 0865515000217
GMDN Terms# Term, Definition table Term Definition Orthodontic vibrator An electronic device designed to be used in the home during treatment with orthodontic appliances (e.g., brackets, aligners) to provide small vibrations for gently accelerating the movement of anterior teeth, guided by the appliances, to help reduce treatment time and pain. It is in the form of a biteable plastic mouthpiece attached to a hands-free vibratory unit. This is a reusable device.
Regulatory Flags# DUNS number 806256967 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00865515000200 AcceleDent Aura 2016-09-06
Other Devices Sharing Product Codes# 
orthoaccel.com