FDA.reportPublic FDA data

ORJ

Primary DI
D115W12112L1
Brand
ORJ
Company
Fortune Worldwide LLC
Model
W121-12L
Device description
Orthodontic Niti Archwires for Teeth Correction
Published
2022-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECNClamp, Wire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D115W12112L1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949163229
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D115AFA2151ORJAFA2152023-06-12
D115AFA2551ORJAFA2552023-06-12
D115GP202251ORJGP202252023-06-12
D115PP202251ORJPP202252023-06-12
D115W41112U1ORJW411-12U2023-06-12
D115W63010061ORJW630-10062022-11-08
D115D6011111ORJD601-1112022-11-04
D115W1211925U1ORJW121-1925U2022-11-04
D115TB3224001ORJTB32-24002022-10-28
D115F201021ORJF201-022023-01-23
D115F201031ORJF201-032023-01-23
D115F20104L1ORJF201-04L2023-01-23
D115F20104R1ORJF201-04R2023-01-23
D115F202021ORJF202-022023-01-23
D115F301011ORJF301-012023-01-23
D115F301021ORJF301-022023-01-23
D115F307011ORJF307-012023-01-23
D115W73014071ORJW730-14072022-11-08
D115D6012101ORJD601-2102022-11-04
D115J62151151ORJJ621-51152022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456204962JMUJMU DENTAL, INCECN2026-06-25
00840456204979JMUJMU DENTAL, INCECN2026-06-25
00840456204986JMUJMU DENTAL, INCECN2026-06-25
00840456204993JMUJMU DENTAL, INCECN2026-06-25
00840456205006JMUJMU DENTAL, INCECN2026-06-25
00840456205013JMUJMU DENTAL, INCECN2026-06-25
00840456205266JMUJMU DENTAL, INCECN2026-06-25
00840456205273JMUJMU DENTAL, INCECN2026-06-25
00840456205280JMUJMU DENTAL, INCECN2026-06-25
00840456205754JMUJMU DENTAL, INCECN2026-06-25
00840456205761JMUJMU DENTAL, INCECN2026-06-25
00840456205778JMUJMU DENTAL, INCECN2026-06-25
00840456205785JMUJMU DENTAL, INCECN2026-06-25
00840456205792JMUJMU DENTAL, INCECN2026-06-25
00840456205808JMUJMU DENTAL, INCECN2026-06-25
00840456205815JMUJMU DENTAL, INCECN2026-06-25
00840456205822JMUJMU DENTAL, INCECN2026-06-25
00840456205839JMUJMU DENTAL, INCECN2026-06-25
00840456205846JMUJMU DENTAL, INCECN2026-06-25
00840456205853JMUJMU DENTAL, INCECN2026-06-25
00840456205860JMUJMU DENTAL, INCECN2026-06-25
00840456206072JMUJMU DENTAL, INCECN2026-06-25
00840456206355JMUJMU DENTAL, INCECN2026-06-25
00840456221730JMUJMU DENTAL, INCECN2026-05-11
00840456221747JMUJMU DENTAL, INCECN2026-05-11
006522210993343M™ Unitek™ Intraoral Attachments3M UNITEK CORPORATIONECN2026-05-07
00190746203770Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203787Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203794Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203800Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21