FDA.reportPublic FDA data

EdgeEndo

Primary DI
00810213814628
Brand
EdgeEndo
Company
HSG-S Corp.
Model
EE25GLIN
Device description
EdgeFlow E25G-L Needle
Published
2026-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EKRPLUGGER, ROOT CANAL, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810213814628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810213814628008102138146288102138146280810213814628

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation system handpiece, heat conductingA handpiece, which is part of an endodontic obturation system, intended to control through its hand-switch an electrical current from the generator to the tip of an attached dental instrument where it is converted to resistive heat used to test tooth response to thermal stimulus during treatment involving root canal obturation procedures. This is a reusable device.

Regulatory Flags#

DUNS number
144949235
Device count
1
DM exempt
true
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
false
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
00810213814550EdgeEndoEE20GLIN2026-08-31
00810213814567EdgeEndoEE20GMIN2026-08-31
00810213814581EdgeEndoEE20GSIN2026-08-31
00810213814598EdgeEndoEE23GLIN2026-08-31
00810213814604EdgeEndoEE23GMIN2026-08-31
00810213814635EdgeEndoEE25GMIN2026-08-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810137JAS Heat Plugger TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKR2026-09-24
00810213814550EdgeEndoHSG-S Corp.EKR2026-08-31
00810213814567EdgeEndoHSG-S Corp.EKR2026-08-31
00810213814581EdgeEndoHSG-S Corp.EKR2026-08-31
00810213814598EdgeEndoHSG-S Corp.EKR2026-08-31
00810213814604EdgeEndoHSG-S Corp.EKR2026-08-31
00810213814635EdgeEndoHSG-S Corp.EKR2026-08-31
G8791062850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
G8791062880DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKR2026-08-08
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
00348783009002Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009019Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009026Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009033Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783009057Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-30
00348783008975Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008982Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008999Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009125Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29