FDA.reportPublic FDA data

ORTHO ARCH

Primary DI
D9094300201
Brand
ORTHO ARCH
Company
Ortho Arch Company Inc
Model
430-020
Device description
CRIMPABLE CURVED MULTI HOOK - LEFT (10 PACK)
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
ECNClamp, Wire, Orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9094300201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic lockA dental device intended to be placed on an orthodontic archwire or rod via screwing, crimping, or soldering, for orthodontic spring activation and/or to prevent the archwire from sliding within the brackets. It may be designed in various forms (e.g., Gurin lock, stop). It does not incorporate a pin or hook. 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
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
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
00190746203817Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203824Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203831Bondable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
10371347023203Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023210Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023227Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023234Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023241Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023258Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023265Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023272Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023289Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
07908611211644CRIMPABLE BALL HOOK - UNIVERSAL - 2.7MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211651CRIMPABLE BALL HOOK - UNIVERSAL - 4,0MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211668BUTTON WITH LONG HOOK FOR BONDING - LEFT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212603BUTTON WITH LONG HOOK FOR BONDING - RIGHT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212634ORTHODONTIC SPUR - 50UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212665ORTHODONTIC BITE TURBO - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212672LINGUAL BUTTON PERFORATED BASE FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611213815BUTTON WITH CAPLIN HOOK FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214928LONG CRIMPABLE HOOK - RECTANGULAR - LEFT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214935LONG CRIMPABLE HOOK - RECTANGULAR - RIGHT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
00190707124267Ortho Technology®Ortho Organizers, Inc.ECN2025-10-17