FDA.reportPublic FDA data

EdgeEndo

Primary DI
00810213810002
Brand
EdgeEndo
Company
HSG-S Corp.
Model
EUCF621
Device description
EdgeUtopia C-File, Size 6, 21mm
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
00810213810002PrimaryGS10
80810213810008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213810002008102138100028102138100020810213810002
8081021381000880810213810008

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
00810213812419EdgeEndoEOBU2021SU2026-06-24
00810213812426EdgeEndoEOBU2025SU2026-06-24
00810213812433EdgeEndoEOBU2031SU2026-06-24
00810213812440EdgeEndoEOBU2521SU2026-06-24
00810213812457EdgeEndoEOBU2525SU2026-06-24
00810213812464EdgeEndoEOBU2531SU2026-06-24
00810213812471EdgeEndoEOBU3521SU2026-06-24
00810213812488EdgeEndoEOBU3525SU2026-06-24
00810213812495EdgeEndoEOBU3531SU2026-06-24
00810213812501EdgeEndoEOBU4521SU2026-06-24
00810213812518EdgeEndoEOBU4525SU2026-06-24
00810213812525EdgeEndoEOBU4531SU2026-06-24
00810213812532EdgeEndoEOBUA21SU2026-06-24
00810213812549EdgeEndoEOBUA25SU2026-06-24
00810213812556EdgeEndoEOBUA31SU2026-06-24
00810213812563EdgeEndoEOBURG1421SU2026-06-24
00810213812570EdgeEndoEOBURG1425SU2026-06-24
00810213812587EdgeEndoEOBURG1431SU2026-06-24
00810213812594EdgeEndoETBUA21SU2026-06-24
00810213812600EdgeEndoETBUA25SU2026-06-24

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