FDA.reportPublic FDA data

X-Factor™ Minimally Invasive NiTi Files 25/.04 (21mm)

Primary DI
07540172013147
Brand
X-Factor™ Minimally Invasive NiTi Files 25/.04 (21mm)
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
311009
Catalog number
311009
Device description
Endodontic surgical files
Published
2020-03-17
Public version status
New
Distribution status
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
07540172013147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172013147075401720131477540172013147

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length21Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540172009539Frost™ 37% Phosphoric Acid Etch 30ml3453013453012016-09-16
07540172009546Frost™ 37% Phosphoric Acid Etch 5ml3455013455012016-09-16
07540172010795Max Etch 35% Phosphoric Acid Etch 30ml3453023453022016-09-16
07540172010801Max Etch 35% Phosphoric Acid Etch 5ml3455033455032016-09-16
07540172019125G5 All-Purpose Desensitizer2261052261052024-09-23
07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172002363Green Mouldable Edentulous Trays Size 211884211884212020-10-22
07540172001861D-Fine Double Diamond™ Primary Polisher Refill #091315091315092020-10-22
07540172001953D-Fine Double Diamond™ Final High Shine Refill #091325091325092020-10-22

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