FDA.reportPublic FDA data

JMU

Primary DI
00840456212707
Brand
JMU
Company
JMU DENTAL, INC
Model
21518005
Device description
JMU HAND USE FILES, C+FILES, Stainless Steel, #08(25mm), Non-sterilized Packing, 6pcs/Pk
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456212707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456212707008404562127078404562127070840456212707

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, reusableA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
081258380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456221891JMU520190082026-06-08
00840456221907JMU520190092026-06-08
00840456221914JMU520190102026-06-08
00840456221921JMU520190112026-06-08
00840456221938JMU520190122026-06-08
00840456221945JMU520190132026-06-08
00840456222317JMU520190142026-06-08
00840456222324JMU520190152026-06-08
00840456222331JMU520190162026-06-08
00840456222348JMU520190172026-06-08
00840456222355JMU520190182026-06-08
00840456222362JMU520190192026-06-08
00840456201053JMU321130012026-06-05
00840456201060JMU321130022026-06-05
00840456201077JMU321130032026-06-05
00840456201275JMU321010102026-06-05
00840456201282JMU321010112026-06-05
00840456201299JMU321010122026-06-05
00840456201305JMU321010152026-06-05
00840456201312JMU321010142026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830090EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830106EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830113EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461054EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461061EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461078EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461085EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461092EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461108EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461115EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461122EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461139EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461146EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461153EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461160EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461177EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461184EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461191EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461207EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461214EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461221EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461238EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461245EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461252EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461269EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452462235EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462242EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462259EdgeTaperFKG Dentaire SàrlEKS2026-06-03