K-Files 21mm 010, pu: 6 pcs

Primary DI
07630049902046
Brand
K-Files 21mm 010, pu: 6 pcs
Company
Diaswiss SA
Model
121021.010
Device description
Manual instrument for endodontic intraoral use
Published
2023-10-02
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

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
07630049902053PrimaryGS10
07630049902046Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630049902053076300499020537630049902053
07630049902046076300499020467630049902046

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
480296552
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630049901063Porcelain Veneer Set1VeneerSetPD2023-12-01
07630049901087Porcelain Veneer Set1PhucDangSet2023-12-01
07630049901100A-Z Modern Cavity Set1ModernCavitySe2023-12-01
07630049901391RootEX standard 0.8 (sample)935L.Set008-sam2023-12-01
07630049901407RootEX standard 011(sample)935L.Set011-sam2023-12-01
07630049901414RootEX standard 1.6 (sample)935L.Set016-sam2023-12-01
07630049901421RootEX standard 1.8 (sample)935L.Set018-sam2023-12-01
07630049901438RootEX standard 0.8 (sample)935K.Set008-sam2023-12-01
07630049901452RootEX standard 1.1 (sample)935K.Set011-sam2023-12-01
07630049901469RootEX standard 1.6 (sample)935K.Set016-sam2023-12-01
07630049901483RootEX standard 1.8 (sample)935K.Set018-sam2023-12-01
07630049901490Phuc Dang Set21PhucDangSet22023-12-01
07630049901520Hedstroem files 25mm 045 - 080, pu: 6325025.45802023-12-01
07630049901537Reamer 31mm 45 - 80, pu: 6 pcs231031.45802023-12-01
076300499018721Dr.XochipaSet Full Prep Set1Dr.XochipaSet2023-12-01
07630049902817Surgicut Set314Z164-set.0152023-12-01
07630049902824Porcelain Adjustment Kit RA K011AdjustmentKit2023-12-01
07630049950894rootEX instrument set short, pu: 2 pcs937K.Set2023-12-01
07630049950979rootEX instrument set long, pu: 2 pcs937L.Set2023-12-01
07630049951006Set FG diamonds short shank1ShortSet2023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630049901858rootEX instrument short 0,8 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049902053K-Files 21mm 010, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049950856rootEX instrument short 1,3 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049950870rootEX instrument short 1,8 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049950917rootEX instrument long 0,8 mm, pu: 6 pDiaswiss SAEKS2023-10-02
07630049950931rootEX instrument long 1,3 mm, pu: 6 pDiaswiss SAEKS2023-10-02
07630049950955rootEX instrument long 1,8 mm, pu: 6 pDiaswiss SAEKS2023-10-02
07630049952584rootEX drill short shank 0,8 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049952591rootEX drill short shank 1,1 mm, pu: 6Diaswiss SAEKS2023-10-02
07630049986831K-Files 29mm 008, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986848K-Files 29mm 010, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986862K-Files 29mm 015, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986886K-Files 29mm 020, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986909K-Files 29mm 025, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986923K-Files 29mm 030, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986947K-Files 29mm 035, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986961K-Files 29mm 040, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049986985K-Files 29mm 045, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987005K-Files 29mm 050, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987029K-Files 29mm 055, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987043K-Files 29mm 060, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987067K-Files 29mm 070, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987081K-Files 29mm 080, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987203Hedstroem files 21mm 055, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987357Hedstroem files 25mm 055, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987401Hedstroem files 29mm 008, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987418Hedstroem files 29mm 010, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987432Hedstroem files 29mm 015, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987456Hedstroem files 29mm 020, pu: 6 pcsDiaswiss SAEKS2023-10-02
07630049987470Hedstroem files 29mm 025, pu: 6 pcsDiaswiss SAEKS2023-10-02