FDA.reportPublic FDA data

JMU

Primary DI
00840456205402
Brand
JMU
Company
JMU DENTAL, INC
Model
38702031
Device description
JMU Mini Brackets, Monoblock, Roth 0.022, Hooks on 3,4,5, 20 pcs/box
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJFBracket, Metal, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456205402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456205402008404562054028404562054020840456205402

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
081258380
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456201336JMU353540242026-08-18
00840456201343JMU353540252026-08-18
00840456201350JMU353540262026-08-18
00840456201367JMU353540272026-08-18
00840456201374JMU353540282026-08-18
00840456201381JMU353540292026-08-18
00840456201398JMU353540302026-08-18
00840456201404JMU353540312026-08-18
00840456201411JMU353540322026-08-18
00840456203163JMU170090042026-08-18
00840456207123JMU170090012026-08-18
00840456207130JMU170090022026-08-18
00840456216477JMU353540402026-08-18
00840456216484JMU353540392026-08-18
00840456216491JMU353540382026-08-18
00840456223628JMU170090032026-08-18
00840456223635JMU190010012026-08-18
00840456223642JMU190010022026-08-18
00840456223659JMU301020012026-08-18
00840456223789JMU350100042026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746141249Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141263Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141454Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141461Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141515Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141522Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175442Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175459Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746176296Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746176302Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746161575Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746174957Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175268Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175275Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175510Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175954Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175961Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175978Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175985Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176159Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176166Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176753Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176760Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176951Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176968Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177132Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177149Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177156Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177163Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26