FDA.reportPublic FDA data

NITI PALATAL EXPANDER

Primary DI
D90927146006
Brand
NITI PALATAL EXPANDER
Company
Ortho Arch Company Inc
Model
271-460
Catalog number
271-460
Device description
NITI PALATAL EXPANDER - 44MM
Published
2023-06-13
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
D90927146006PrimaryHIBCC0

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
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
07908611211736LINGUAL RETAINER STRAIGHT WIRES - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611212641LINGUAL RETAINER CHAIN - SOFT - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611213853LINGUAL RETAINER CHAIN - HARD - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611210333ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211163PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211170PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611210319KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-03
07908470704738KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTICORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704776KIT ADVANCED METAL BRACKETS MBT 0.022 10 SETS + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704912KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07899439270497ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270503ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270510ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439272583ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439292949ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07908611210029"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210036"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210043"PROMO KIT ADVANCED MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210050"PROMO KIT ADVANCED MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07895742151591MorelliDental Morelli LtdaDZC2021-04-30
07895742161194MorelliDental Morelli LtdaDZC2021-04-30
07895742161200MorelliDental Morelli LtdaDZC2021-04-30
07895742161217MorelliDental Morelli LtdaDZC2021-04-30
07895742161224MorelliDental Morelli LtdaDZC2021-04-30
07895742161231MorelliDental Morelli LtdaDZC2021-04-30
07895742161248MorelliDental Morelli LtdaDZC2021-04-30
07895742161255MorelliDental Morelli LtdaDZC2021-04-30
07895742161262MorelliDental Morelli LtdaDZC2021-04-30