FDA.reportPublic FDA data

JMU

Primary DI
00840456220504
Brand
JMU
Company
JMU DENTAL, INC
Model
43303010
Device description
JMU Prophy Angle with firm cup, 105°, AQUA, 1pc/individual bag, sold by pack, 100pcs/pack
Published
2026-07-07
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
EHKCup, Prophylaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456220504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456220504008404562205048404562205040840456220504

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456206942JMU320010242026-07-09
00840456207024JMU320010212026-07-09
00840456207031JMU320010222026-07-09
00840456207048JMU320010232026-07-09
00840456207055JMU320010252026-07-09
00840456207062JMU320010262026-07-09
00840456207079JMU320010272026-07-09
00840456207086JMU320010282026-07-09
00840456207093JMU320010292026-07-09
00840456207109JMU320010302026-07-09
00840456209332JMU323030012026-07-09
00840456209349JMU323030022026-07-09
00840456209356JMU323030032026-07-09
00840456214138JMU320010202026-07-09
00840456214145JMU320010192026-07-09
00840456214152JMU320010182026-07-09
00840456214169JMU320010172026-07-09
00840456214176JMU320010162026-07-09
00840456214183JMU320010152026-07-09
00840456214190JMU320010142026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456220474JMUJMU DENTAL, INCEHK2026-07-07
00840456220481JMUJMU DENTAL, INCEHK2026-07-07
00840456220498JMUJMU DENTAL, INCEHK2026-07-07
00840456220115JMUJMU DENTAL, INCEHK2026-06-25
00840456220122JMUJMU DENTAL, INCEHK2026-06-25
00840456220139JMUJMU DENTAL, INCEHK2026-06-25
00840456220146JMUJMU DENTAL, INCEHK2026-06-25
00840456220153JMUJMU DENTAL, INCEHK2026-06-25
00840456220160JMUJMU DENTAL, INCEHK2026-06-25
00840456220177JMUJMU DENTAL, INCEHK2026-06-25
00840456220184JMUJMU DENTAL, INCEHK2026-06-25
00840456220191JMUJMU DENTAL, INCEHK2026-06-25
00840456220207JMUJMU DENTAL, INCEHK2026-06-25
00840456220214JMUJMU DENTAL, INCEHK2026-06-25
00840456220221JMUJMU DENTAL, INCEHK2026-06-25
00840456220238JMUJMU DENTAL, INCEHK2026-06-25
00840456220245JMUJMU DENTAL, INCEHK2026-06-25
00840456220252JMUJMU DENTAL, INCEHK2026-06-25
00840456220269JMUJMU DENTAL, INCEHK2026-06-25
00840456220276JMUJMU DENTAL, INCEHK2026-06-25
07897990300103PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300110PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300127PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300219PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300233PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300264PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300271PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300288PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300295PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300325PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18