K File 21mm 45

Primary DI
00810118100222
Brand
K File 21mm 45
Company
NUSMILE, LTD.
Model
ZKFILE2145
Device description
Blister of 6 units
Published
2022-10-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00810118100222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118100222008101181002228101181002220810118100222

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or reamer. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags#

DUNS number
185497372
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118108075NuSmile NuCemSNUCEM2026-04-21
08809911118505NuSmile NuCemNCRSK2026-04-14
08809911118512NuSmile NuCemNCRPK2026-04-14
00810118107962NuSmile Bite Stick / Band SeaterBS-0012026-04-08
00810118107979NuSmile Heavy Band PusherBP-0022026-04-08
00810118107986NuSmile 3 Jaw PlierTJP-0032026-04-08
00810118107993NuSmile Bird Beak PlierBBP-0042026-04-08
00810118108006NuSmile Band / Crown Crimping PlierBCP-0052026-04-08
00810118108013NuSmile Heavy Curved ScissorsHCS-0062026-04-08
00810118108020NuSmile Posterior Band RemoverPBR-0072026-04-08
00810118108037NuSmile Tube Crimping PlierTCP-0082026-04-08
00810118108044NuSmile Contouring PlierCP-0092026-04-08
00810118108051NuSmile Hard Wire CutterHWC-0102026-04-08
00810118107948NuSmile NuCemNCRSKI2026-04-08
00810118107955NuSmile NuCemNCRPKI2026-04-08
00810118108068Zarc by Avalon Biomed NanoShaper Gutta-Percha Assorted ZN1-ZN5 (Sample)SGP-N1992026-04-06
00810118107931NuSmile NuCemNCRPK2026-04-02
00810118107924NuSmile NuCemNCRSK2026-04-01
00810118103650Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)63440032026-01-15
00810118105555Ultradent MTApex 5.0 g Powder138692026-01-14

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