FDA.reportPublic FDA data

VaryFlex Flow, VFF 25mm Size 45/04

Primary DI
05060940379463
Brand
VaryFlex Flow, VFF 25mm Size 45/04
Company
ENDOPERFECTION LIMITED
Model
VFF254504
Published
2025-06-19
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
05060940379463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060940379463050609403794635060940379463

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

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
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
05060940379401VaryFlex OS, VFOS, 20/07, 19mmVFOS2007192024-06-19
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
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812679EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812686EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812693EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812709EdgeEndoHSG-S Corp.EKS2026-06-24