FDA.reportPublic FDA data

VPro

Primary DI
00852673007103
Brand
VPro
Company
PROPEL ORTHODONTICS LLC
Model
ASM-20018
Device description
VPro is an orthodontic accessory device intended for use during orthodontic treatment to facilitate minor anterior tooth movement.
Published
2020-03-23
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852673007103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852673007103008526730071038526730071030852673007103

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
4088546710customercare@propelortho.com

Regulatory Flags#

DUNS number
117334253
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852673007073PropelASM-20021ASM-200212018-03-06
00852673007240Acceledent OptimaASM-200312020-07-31
00852673007004PropelASM-20010ASM-200102016-12-28
00852673007189VPro+ASM-200232020-03-17
00852673007127HyperByteASM-20018-052020-01-14
00852673007011PropelASM-20018ASM-200182016-12-28
00852673007028PropelASM-20010-04ASM-20010-042016-12-28
00852673007035PropelASM-20010-01ASM-20010-012016-12-28
00852673007042PropelASM-20010-03ASM-20010-032016-12-28
00852673007059PropelASM-20010-02ASM-20010-022016-12-28
00852673007066PropelASM-20022ASM-200222018-03-06
00852673007080PropelASM-20018-04ASM-20018-042018-03-09
00852673007097PropelASM-200232018-04-25

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
00852673007189VPro+PROPEL ORTHODONTICS LLCOYH2020-03-17
00852673007127HyperBytePROPEL ORTHODONTICS LLCOYH2020-01-14
00852673007073PropelPROPEL ORTHODONTICS LLCOYH2018-03-06
00865515000217AcceleDent ORTHOACCEL TECHNOLOGIES, INC.OYH2017-06-16
00865515000200AcceleDentORTHOACCEL TECHNOLOGIES, INC.OYH2016-09-06