FDA.reportPublic FDA data

EdgeEndo

Primary DI
00810213810286
Brand
EdgeEndo
Company
HSG-S Corp.
Model
EUKF2025
Device description
EdgeUtopia K-File, Size 20, 25mm
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00810213810286PrimaryGS10
80810213810282Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213810286008102138102868102138102860810213810286
8081021381028280810213810282

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
144949235
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810213814697EdgeEndo® EdgeCore™ for EdgeTaper™ET2006C2026-08-19
00810213814703EdgeEndo® EdgeCore™ for EdgeTaper™ET2506C2026-08-19
00810213814710EdgeEndo® EdgeCore™ for EdgeTaper™ET3006C2026-08-19
00810213814727EdgeEndo® EdgeCore™ for EdgeTaper™ET4006C2026-08-19
00810213814741EdgeEndo® EdgeFill™ for EdgeTaper™ET2006O2026-08-19
00810213814758EdgeEndo® EdgeFill™ for EdgeTaper™ET2506O2026-08-19
00810213814765EdgeEndo® EdgeFill™ for EdgeTaper™ET3006O2026-08-19
00810213814789EdgeEndo® EdgeFill™ for EdgeTaper™ET5006O2026-08-19
00810213814796EdgeEndo® EdgeVerify™X72006V2026-08-19
00810213814802EdgeEndo® EdgeVerify™X72506V2026-08-19
00810213814819EdgeEndo® EdgeVerify™X73006V2026-08-19
00810213814833EdgeEndo® EdgeVerify™X74006V2026-08-19
00810213814840EdgeEndo® EdgeVerify™X74506V2026-08-19
00810213814857EdgeEndo® EdgeVerify™X75006V2026-08-19
00810213814864EdgeEndo® EdgeCore™ for EdgeOne™EOPSM20C2026-08-19
00810213814871EdgeEndo® EdgeCore™ for EdgeOne™EOPPRI25C2026-08-19
00810213814895EdgeEndo® EdgeCore™ for EdgeOne™EOPLG45C2026-08-19
00810213814901EdgeEndo® EdgeFill™ for EdgeOne™EOPSM20O2026-08-19
00810213814918EdgeEndo® EdgeFill™ for EdgeOne™EOPPRI25O2026-08-19
00810213814932EdgeEndo® EdgeFill™ for EdgeOne™EOPLG45O2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850085821171K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821188K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821195K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821201H FilesCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
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