FDA.reportPublic FDA data

AcceleDent

Primary DI
00865515000200
Brand
AcceleDent
Company
ORTHOACCEL TECHNOLOGIES, INC.
Model
Aura
Device description
Accelerated Orthodontic Treatment
Published
2016-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYHOrthodontic Vibratory Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYHOrthodontic Vibratory AccessoryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130643000ACCELEDENT AURAOrthoaccel Technologies, Inc.2013-04-23OYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865515000200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865515000200008655150002008655150002000865515000200

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic vibratorAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-866-4919customerservice@orthoaccel.com

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 DIBrandModelCatalogPublished
00865515000217AcceleDent Optima2017-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D001V181001SureSmileDentsply International Inc.OYH2022-11-11
D001V181021SureSmileDentsply International Inc.OYH2022-11-11
D001V181151ByteDentsply International Inc.OYH2022-11-11
00852673007240Acceledent OptimaPROPEL ORTHODONTICS LLCOYH2020-07-31
00852673007103VProPROPEL ORTHODONTICS LLCOYH2020-03-23
00852673007189VPro+PROPEL ORTHODONTICS LLCOYH2020-03-17
00852673007127HyperBytePROPEL ORTHODONTICS LLCOYH2020-01-14
00852673007073PropelPROPEL ORTHODONTICS LLCOYH2018-03-06
00865515000217AcceleDent ORTHOACCEL TECHNOLOGIES, INC.OYH2017-06-16