FDA.reportPublic FDA data

ORJ

Primary DI
D115J62251351
Brand
ORJ
Company
Fortune Worldwide LLC
Model
J622-5135
Device description
Orthodontic Metal Tubes 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
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D115J62251351PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. 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
00840456203514JMUJMU DENTAL, INCDZD2026-06-25
00840456203521JMUJMU DENTAL, INCDZD2026-06-25
00840456203538JMUJMU DENTAL, INCDZD2026-06-25
00840456203545JMUJMU DENTAL, INCDZD2026-06-25
00840456203552JMUJMU DENTAL, INCDZD2026-06-25
00840456205297JMUJMU DENTAL, INCDZD2026-06-25
00840456205303JMUJMU DENTAL, INCDZD2026-06-25
00840456205310JMUJMU DENTAL, INCDZD2026-06-25
00840456205327JMUJMU DENTAL, INCDZD2026-06-25
00840456205334JMUJMU DENTAL, INCDZD2026-06-25
00840456205341JMUJMU DENTAL, INCDZD2026-06-25
00840456205358JMUJMU DENTAL, INCDZD2026-06-25
00840456205365JMUJMU DENTAL, INCDZD2026-06-25
00840456205372JMUJMU DENTAL, INCDZD2026-06-25
00840456206034JMUJMU DENTAL, INCDZD2026-06-25
00840456206041JMUJMU DENTAL, INCDZD2026-06-25
00840456206058JMUJMU DENTAL, INCDZD2026-06-25
00840456206089JMUJMU DENTAL, INCDZD2026-06-25
00840456206096JMUJMU DENTAL, INCDZD2026-06-25
00840456206102JMUJMU DENTAL, INCDZD2026-06-25
00840456206119JMUJMU DENTAL, INCDZD2026-06-25
00840456206126JMUJMU DENTAL, INCDZD2026-06-25
00840456206133JMUJMU DENTAL, INCDZD2026-06-25
00840456206140JMUJMU DENTAL, INCDZD2026-06-25
00840456206157JMUJMU DENTAL, INCDZD2026-06-25
00840456206164JMUJMU DENTAL, INCDZD2026-06-25
00840456206171JMUJMU DENTAL, INCDZD2026-06-25
00840456206188JMUJMU DENTAL, INCDZD2026-06-25
00840456206195JMUJMU DENTAL, INCDZD2026-06-25
00840456206201JMUJMU DENTAL, INCDZD2026-06-25