FDA.reportPublic FDA data

MM K-Files

Primary DI
J015600407021
Brand
MM K-Files
Company
MICRO MEGA
Model
n008 L31 ISO M09
Catalog number
60040702
Device description
Endodontic instruments for professionnal use only
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
J015600407029PackageHIBCC10In Commercial Distribution
J015600407021PrimaryHIBCC0
J015600407020Unit of UseHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
276075371
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J015600406651MM K-Filesn006 L21 ISO M09600406652026-04-08
J015600406661MM K-Filesn008 L21 ISO M09600406662026-04-08
J015600406671MM K-Filesn010 L21 ISO M09600406672026-04-08
J015600406681MM K-Filesn015 L21 ISO M09600406682026-04-08
J015600406691MM K-Filesn020 L21 ISO M09600406692026-04-08
J015600406701MM K-Filesn025 L21 ISO M09600406702026-04-08
J015600406711MM K-Filesn030 L21 ISO M09600406712026-04-08
J015600406721MM K-Filesn035 L21 ISO M09600406722026-04-08
J015600406731MM K-Filesn040 L21 ISO M09600406732026-04-08
J015600406741MM K-Filesn045 L21 ISO M09600406742026-04-08
J015600406751MM K-Filesn050 L21 ISO M09600406752026-04-08
J015600406761MM K-Filesn055 L21 ISO M09600406762026-04-08
J015600406771MM K-Filesn060 L21 ISO M09600406772026-04-08
J015600406781MM K-Filesn070 L21 ISO M09600406782026-04-08
J015600406791MM K-Filesn080 L21 ISO M09600406792026-04-08
J015600406821MM K-Filesn006 L25 ISO M09600406822026-04-08
J015600406831MM K-Filesn008 L25 ISO M09600406832026-04-08
J015600406841MM K-Filesn010 L25 ISO M09600406842026-04-08
J015600406851MM K-Filesn015 L25 ISO M09600406852026-04-08
J015600406861MM K-Filesn020 L25 ISO M09600406862026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452460194Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460200Edge EvolveFKG Dentaire SàrlEKS2026-10-27
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07640452460224Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460231Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460248Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460255Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460262Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460279Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460286Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460293Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460309Edge EvolveFKG Dentaire SàrlEKS2026-10-27
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07640452460330Edge EvolveFKG Dentaire SàrlEKS2026-10-27
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07640452460354Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460361Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460378Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460385Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460392Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460408Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460415Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460422Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460439Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460446Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460453Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460460Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460477Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460484Edge EvolveFKG Dentaire SàrlEKS2026-10-27