FDA.reportPublic FDA data

M-access® K-REAMER

Primary DI
J003A11MA021090121
Brand
M-access® K-REAMER
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
A11MA02109012
Catalog number
A11MA02109012
Device description
Endodontic Instrument
Published
2022-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKPREAMER, PULP CANAL, ENDODONTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003A11MA021090121PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00N/A

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J0030525020Z1Gutta Percha Points ISO0525020Z0525020Z2026-08-26
J0030525025Z1Gutta Percha Points ISO0525025Z0525025Z2026-08-26
J0030525030Z1Gutta Percha Points ISO0525030Z0525030Z2026-08-26
J0030525035Z1Gutta Percha points0525035Z0525035Z2026-08-26
J0030525040Z1Gutta Percha points0525040Z0525040Z2026-08-26
J0030525045Z1Gutta Percha points0525045Z0525045Z2026-08-26
J0030525050Z1Gutta Percha points0525050Z0525050Z2026-08-26
J0030525055Z1Gutta Percha points0525055Z0525055Z2026-08-26
J0030525060Z1Gutta Percha points0525060Z0525060Z2026-08-26
J0030525160Z1Gutta Percha points0525160Z0525160Z2026-08-26
J0030525165Z1Gutta Percha Points GP0525165Z0525165Z2026-08-26
J0030530F1Gutta Percha Points GP0530F0530F2026-08-26
J0030530FF1Gutta Percha Points GP0530FF0530FF2026-08-26
J0030530FFZ1Gutta Percha Points GP0530FFZ0530FFZ2026-08-26
J0030530FM1Gutta Percha Points GP0530FM0530FM2026-08-26
J0030530FMZ1Gutta Percha Points GP0530FMZ0530FMZ2026-08-26
J0030530FZ1Gutta Percha Points GP0530FZ0530FZ2026-08-26
J0030530L1Gutta Percha Points GP0530L0530L2026-08-26
J0030530M1Gutta Percha Points GP0530M0530M2026-08-26
J0030530MF1Gutta Percha Points GP0530MF0530MF2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630049902770Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990104Reamer 29mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990128Reamer 29mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990142Reamer 29mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990166Reamer 29mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990180Reamer 29mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990203Reamer 29mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990227Reamer 29mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990241Reamer 29mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990265Reamer 29mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990289Reamer 29mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990302Reamer 29mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990326Reamer 29mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990340Reamer 29mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049990364Reamer 29mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996595Reamer 21mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996601Reamer 21mm 010, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996618Reamer 21mm 015, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996625Reamer 21mm 020, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996632Reamer 21mm 025, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996649Reamer 21mm 030, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996656Reamer 21mm 035, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996663Reamer 21mm 040, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996670Reamer 21mm 045, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996687Reamer 21mm 050, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996694Reamer 21mm 055, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996700Reamer 21mm 060, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996717Reamer 21mm 070, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996724Reamer 21mm 080, pu: 6 pcsDiaswiss SAEKP2023-10-02
07630049996731Reamer 25mm 008, pu: 6 pcsDiaswiss SAEKP2023-10-02