FDA.reportPublic FDA data

ORTHO ARCH

Primary DI
D90927010916
Brand
ORTHO ARCH
Company
Ortho Arch Company Inc
Model
270-109
Device description
"ORTHO-LINKS LINGUAL RETAINER WIRE 8"" (8/PK)"
Published
2025-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D90927010916PrimaryHIBCC0

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
020956330
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D90927021918ORTHO ARCH270-2192025-09-29
D90943001914ORTHO ARCH430-0192025-09-29
D9094300201ORTHO ARCH430-0202025-09-29
D90992402115ORTHO ARCH924-0212025-09-29
D90992402216ORTHO ARCH924-0222025-09-29
D909924023G1ORTHO ARCH924-023G2025-09-29
D909924024G1ORTHO ARCH924-024G2025-09-29
D909924033F1ORTHO ARCH924-033F2025-09-29
D909924034F1ORTHO ARCH924-034F2025-09-29
D909924043F1ORTHO ARCH924-043F2025-09-29
D909924044F1ORTHO ARCH924-044F2025-09-29
D90992412116ORTHO ARCH924-1212025-09-29
D90992412217ORTHO ARCH924-1222025-09-29
D909924123G1ORTHO ARCH924-123G2025-09-29
D909924124G1ORTHO ARCH924-124G2025-09-29
D909924133F1ORTHO ARCH924-133F2025-09-29
D909924134F1ORTHO ARCH924-134F2025-09-29
D909924141F1ORTHO ARCH924-141F2025-09-29
D909924142F1ORTHO ARCH924-142F2025-09-29
D909924143F1ORTHO ARCH924-143F2025-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25
00840456210123JMUJMU DENTAL, INCDZC2026-06-25
00840456210130JMUJMU DENTAL, INCDZC2026-06-25
00840456211182JMUJMU DENTAL, INCDZC2026-06-25
00840456211199JMUJMU DENTAL, INCDZC2026-06-25
00840456211205JMUJMU DENTAL, INCDZC2026-06-25
00840456211212JMUJMU DENTAL, INCDZC2026-06-25