FDA.reportPublic FDA data

ORTHO ARCH

Primary DI
D909924023G1
Brand
ORTHO ARCH
Company
Ortho Arch Company Inc
Model
924-023G
Device description
.018/.045 U6R DOUBLE CONVERTIBLE -10 TORQUE DIRECT BOND (5)
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
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D909924023G1PrimaryHIBCC0

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
020956330
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D90927010916ORTHO ARCH270-1092025-09-29
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
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
00197998070198SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070204SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070211SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075063SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075674SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101670SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101694SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107887SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107900SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253386SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253393SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253409SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253416SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253423SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253430SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253447SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253454SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253461SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253478SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253485SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253492SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253508SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253515SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253522SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253539SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253546SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253553SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253560SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253577SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253584SolventumSolventum Orthodontics CorporationDZD2026-10-24