FDA.reportPublic FDA data

EdgeEndo

Primary DI
00810213812624
Brand
EdgeEndo
Company
HSG-S Corp.
Model
ETBUF121SU
Device description
EdgeTaper Blaze Utopia™ F1 L21 (20/07V)
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00810213812624PrimaryGS10
80810213812620Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213812624008102138126248102138126240810213812624
8081021381262080810213812620

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
144949235
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00810213812716EdgeEndoHSG-S Corp.EKS2026-06-24