FDA.report

JMU

Primary DI
D930140010110
Brand
JMU
Company
JMU DENTAL, INC
Model
14001011
Device description
JMU Carbide Burs, Inverted Cone, FG #36, 5/pk (ISO No. 010/012)
Published
2024-03-21
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

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D930140010110PrimaryHIBCC0

GMDN Terms

TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

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
false
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 DIBrandModelCatalogPublished
00840456218686JMU229110052026-03-11
00840456218693JMU229110062026-03-11
00840456218709JMU229080322026-03-09
00840456218716JMU229080332026-03-09
00840456218723JMU229080342026-03-09
00840456218730JMU229080352026-03-09
00840456218747JMU229080362026-03-09
00840456218754JMU229080372026-03-09
00840456218761JMU229080382026-03-09
00840456218778JMU229080392026-03-09
00840456219416JMU510060012026-03-09
00840456219423JMU510060022026-03-09
00840456219430JMU510060122026-03-09
00840456219447JMU510060032026-03-09
00840456219454JMU510060142026-03-09
00840456219461JMU510060152026-03-09
00840456218303JMU241050012026-01-20
00840456218174JMU241190012026-01-09
00840456218181JMU241190022026-01-09
00840456217009JMU251010132025-12-31

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Primary DIBrandCompanyProduct codePublished
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00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
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