FDA.reportPublic FDA data

VaryFlex OS, VFOS, 20/07, 19mm

Primary DI
05060940379401
Brand
VaryFlex OS, VFOS, 20/07, 19mm
Company
ENDOPERFECTION LIMITED
Model
VFOS200719
Published
2024-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
05060940379401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060940379401050609403794015060940379401

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.

Regulatory Flags#

DUNS number
224419290
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060940379425VaryFlex Glide, VFG, 21mmVFG212025-06-19
05060940379432VaryFlex Glide, VFG, 31mmVFG312025-06-19
05060940379449VaryFlex Flow, VFF 21mm Size 45/04 VFF2145042025-06-19
05060940379456VaryFlex Flow, VFF 21mm Size 50/04 VFF2150042025-06-19
05060940379463VaryFlex Flow, VFF 25mm Size 45/04 VFF2545042025-06-19
05060940379470VaryFlex Flow, VFF 25mm Size 50/04 VFF2550042025-06-19
05060940379487VaryFlex Flow, VFF 31mm Size 45/04 VFF3145042025-06-19
05060940379494VaryFlex Flow, VFF 31mm Size 50/04 VFF3150042025-06-19
05060940379500VaryFlex Flow, VFF 21mm Size 45/06VFF2145062025-06-19
05060940379517VaryFlex Flow, VFF 21mm Size 50/06VFF2150062025-06-19
05060940379524VaryFlex Flow, VFF 25mm Size 45/06VFF2545062025-06-19
05060940379531VaryFlex Flow, VFF 25mm Size 50/06VFF2550062025-06-19
05060940379548VaryFlex Flow, VFF 31mm Size 45/06VFF3145062025-06-19
05060940379555VaryFlex Flow, VFF 31mm Size 50/06VFF3150062025-06-19
05060940379562VaryFlex Reciprocating, VFRF 50, 21mmVFRF21502025-06-19
05060940379579VaryFlex Reciprocating, VFRF 50, 25mmVFRF25502025-06-19
05060940379586VaryFlex Reciprocating, VFRF 50, 31mmVFRF31502025-06-19
05060940379418VaryFlex OR, VFOR, 20/07, 19mmVFOR2007192025-04-02
05060940376905VaryFlex Neo, 30/04, 25mmVFNEO3004252024-04-04
05060940376912VaryFlex Neo, 35/04, 25mmVFNEO3504252024-04-04

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