FDA.reportPublic FDA data

ORTHO ARCH

Primary DI
D90970011713
Brand
ORTHO ARCH
Company
Ortho Arch Company Inc
Model
700-117
Device description
ANTERIOR BITE RAMP 3MM TIPS & HANDLE (8)
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ECQAligner, Bracket, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECQAligner, Bracket, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D90970011713PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental mouldA hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G859PT20260010Clear Moves AlignerCLEAR MOVES ALIGNERSECQ2026-05-22
G149TBSB1240TBS BASICSACME ENTERPRISE.ECQ2026-05-20
G149TBSB1250TBS BASICSACME ENTERPRISE.ECQ2026-05-20
D175H3DMTA91MemoryTech AlignersHype Align Clear Orthodontics LimitadaECQ2026-02-10
D90970000913ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097000111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001011ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001021ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970010M1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D9097001111ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011511ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700117L1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011814ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970011915ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D909700119S1ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970012310ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
D90970013210ORTHO ARCHOrtho Arch Company IncECQ2025-08-28
00371347018332Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00371347018349Advance Dental ProductsThe Atlanta Dental Supply CompanyECQ2025-01-02
00723896026847SMILEGOODS ALIGNER CHEWIES MINT 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026854SMILEGOODS ALIGNER CHEWIES UNSCENTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026878SMILEGOODS ALIGNER CHEWIES MINT PRACTICON, INC.ECQ2024-08-07
00723896026885SMILEGOODS ALIGNER CHEWIES UNSCENTED PRACTICON, INC.ECQ2024-08-07
00723896026892SMILEGOODS ALIGNER CHEWIES ASSORTED 24 PACKPRACTICON, INC.ECQ2024-08-07
00723896026908SMILEGOODS ALIGNER CHEWIES ASSORTED PRACTICON, INC.ECQ2024-08-07
D90946300111ECLIPSE PASSIVE Ortho Arch Company IncECQ2023-06-20
D90946161116ECLIPSE INTERACTIVEOrtho Arch Company IncECQ2023-06-14
D909270106103LINGUAL BUTTON Ortho Arch Company IncECQ2023-06-13
D90927010613WELDABLE LINGUAL BUTTONSOrtho Arch Company IncECQ2023-06-13
D90927020210DIRECT BOND BUTTONOrtho Arch Company IncECQ2023-06-13