FDA.reportPublic FDA data

OrthoFX

Primary DI
00860003321765
Brand
OrthoFX
Company
ORTHOFX
Model
TB Aligner
Device description
FXBright AlignersFXBright Aligners appears to whiten teeth while correcting dentition.
Published
2020-03-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003321765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003321765008600033217658600033217650860003321765

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4159360006support@care.orthofx.com

Regulatory Flags#

DUNS number
033755180
Device count
1
Premarket exempt
true
Kit
true
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
00860003321799OrthoFX Aligner0192023-09-29
00860003321782OrthoFX NiTime Aligner0132023-09-21
00860003321751OrthoFX Rescue AlignerRA12020-08-26
00860003321706OrthoFXFXTetra2020-07-08
18600033217063OrthoFXZ12020-02-27
00860003321775OrthoFXBB HIK2021-08-05
00860003321737OrthoFX TB Retainer2020-11-24
00086000332174OrthoFXTBRA12020-03-18
00860003321713OrthoFXZR1-rev2020-11-24
18600033217131OrthoFXZR12020-03-11
00860003321720Glo Science6HPGT-rev2020-11-24
00860003321744OrthoFX Home Impression KitHIK1-rev2020-11-24
18600033217445OrthoFXHIK12020-04-24
18600033217209Glo Science6HPGT2020-03-18
18600033217377OrthoFXTBR12020-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906154840993e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841006e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841013e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841020e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841037e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841044e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841051e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841068e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841075e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841082e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841099e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841105e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841112e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841129e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841136e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841143e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841150e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841167e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841174e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841181e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841198e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841204e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841211e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841228e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841235e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841242e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841259e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841266e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841273e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841280e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26