FDA.reportPublic FDA data

JMU

Primary DI
00840456206263
Brand
JMU
Company
JMU DENTAL, INC
Model
38410028
Device description
JMU Lingual Buttons, Bondable Round, With Holes, 10 pcs/bag
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
DZDTube, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456206263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456206263008404562062638404562062630840456206263

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is 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
00840456225424JMU368150012026-10-14
00840456225431JMU368150022026-10-14
00840456225332JMU369430022026-10-13
00840456225349JMU369430032026-10-13
00840456225394JMU463070032026-10-13
00840456225400JMU361020042026-10-13
00840456225417JMU361020052026-10-13
00840456225271JMU520210022026-10-12
00840456224656JMU229080452026-10-09
00840456224663JMU229080462026-10-09
00840456224670JMU229080472026-10-09
00840456224687JMU229080482026-10-09
00840456224694JMU229080492026-10-09
00840456224700JMU229080502026-10-09
00840456224717JMU229080512026-10-09
00840456224724JMU229080522026-10-09
00840456224731JMU229080532026-10-09
00840456225264JMU520210012026-10-09
00840456224861JMU410122532026-09-30
00840456224878JMU410122542026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998070198SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070204SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998070211SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075063SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998075674SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101670SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998101694SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107887SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998107900SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253386SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253393SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253409SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253416SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253423SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253430SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253447SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253454SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253461SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253478SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253485SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253492SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253508SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253515SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253522SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253539SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253546SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253553SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253560SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253577SolventumSolventum Orthodontics CorporationDZD2026-10-24
00197998253584SolventumSolventum Orthodontics CorporationDZD2026-10-24