FDA.report

MANI K-FILES

Primary DI
74546951502002
Brand
MANI K-FILES
Company
MANI, INC.
Model
25mm #60
Device description
MANI K-FILES
Published
2022-10-08
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
false

Related Records

Product Codes

CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546951502003PrimaryGS10
74546951502002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546951502003045469515020034546951502003
7454695150200274546951502002

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
690622428
Device count
6
DM exempt
true
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 DIBrandModelCatalogPublished
74546951616426MANI MICRO FORCEPSSquare Type 27G2026-03-03
74546951616433MANI MICRO FORCEPSRound Type 27G2026-03-03
74546951616440MANI MICRO FORCEPSEXFine Type 27G2026-03-03
74546951619090MANI MICRO FORCEPSSquare Type 25G2026-03-03
74546951619106MANI MICRO FORCEPSRound Type 25G2026-03-03
74546951635595MANI MICRO FORCEPSILM 25G Slim Grip 33mm2026-03-03
74546951635601MANI MICRO FORCEPSILM 27G Slim Grip 33mm2026-03-03
74546951635618MANI MICRO FORCEPSSquare 25G Slim Grip 28mm2026-03-03
74546951635625MANI MICRO FORCEPSRound 25G Slim Grip 28mm2026-03-03
74546951635632MANI MICRO FORCEPSILM 25G Slim Grip 28mm2026-03-03
74546951635649MANI MICRO FORCEPSSquare 27G Slim Grip 28mm2026-03-03
74546951635656MANI MICRO FORCEPSRound 27G Slim Grip 28mm2026-03-03
74546951635663MANI MICRO FORCEPSILM 27G Slim Grip 28mm2026-03-03
74546951635670MANI MICRO FORCEPSEXFine 27G Slim Grip 28mm2026-03-03
74546951635687MANI MICRO FORCEPSSquare 25G Wide Grip 33mm2026-03-03
74546951635694MANI MICRO FORCEPSRound 25G Wide Grip 33mm2026-03-03
74546951635700MANI MICRO FORCEPSILM 25G Wide Grip 33mm2026-03-03
74546951635717MANI MICRO FORCEPSSquare 27G Wide Grip 33mm2026-03-03
74546951635724MANI MICRO FORCEPSRound 27G Wide Grip 33mm2026-03-03
74546951635731MANI MICRO FORCEPSILM 27G Wide Grip 33mm2026-03-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06941877830076EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
06941877830083EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
80810213810008EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810015EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810022EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810039EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810046EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810053EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810060EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810077EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810084EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810091EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810107EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810114EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810121EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810138EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810145EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810152EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810169EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810176EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810183EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810190EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810206EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810213EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810220EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810237EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810244EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810251EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810268EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810275EdgeEndoHSG-S Corp.EKS2026-03-23