FDA.report

NU CERAMIC

Primary DI
D9094649301
Brand
NU CERAMIC
Company
Ortho Arch Company Inc
Model
464-930
Catalog number
464-930
Device description
022 NU CERAMIC MBT 5x5 U&L 345Hk
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NJMBracket, Ceramic, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9094649301PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020956330
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00190746198359Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198366Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198373Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198380Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198397Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198403Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198410Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198427Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198434Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198441Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198458Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198465Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198472Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198489Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198496Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198502Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198519Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198526Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198533Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198540Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198557Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198564Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198571Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198588Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198595Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198601Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198618Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198625Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198632Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23
00190746198649Empower Clear BracketAMERICAN ORTHODONTICS CORPORATIONNJM2026-03-23