FDA.reportPublic FDA data

Gutta Percha Cutter

Primary DI
06979865810014
Brand
Gutta Percha Cutter
Company
DENJOY DENTAL CO.,LTD
Model
Meta Pack
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06979865810014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979865810014069798658100146979865810014

GMDN Terms#

Term, Definition table
TermDefinition
Gutta-percha injectorA hand-held, pistol-shaped, electrically-heated device used to deliver warmed and softened gutta-percha to the dental root canal. Sticks of gutta-percha are inserted into the device and thermally softened before being squeezed out with the ejection trigger through an application tube of varying sizes into the root canal. This is a reusable device.

Regulatory Flags#

DUNS number
529329650
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979865810038JAS MotorJAS M2026-09-24
06979865810045JAS FillJAS F2026-09-24
06979865810052JAS PexJAS P2026-09-24
06979865810069JAS ActivatorJAS A2026-09-24
06979865810076JAS Charging UnitJAS CU2026-09-24
06979865810083JAS Contra-AngleJAS CA2026-09-24
06979865810090JAS Power SupplyJAS PS2026-09-24
06979865810106JAS Activator Ultrasonic TipsJAS UT2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesJAS GPN2026-09-24
06979865810120JAS Gutta-Percha PelletsJAS GPP2026-09-24
06979865810137JAS Heat Plugger TipJAS HPT2026-09-24
06979865810151JAS Unit Endo System plus JAS Pack Gutta-Percha CutterJAS Kit2026-09-24
06979865810168JAS Pack Gutta-Percha CutterJAS Pack2026-09-24
06979865810175JAS Unit Endo SystemJAS Unit2026-09-24
06979865810007Integrated Endo SystemMeet Endo-II2026-03-31
06970873260389Integrated Endo System Meet Endo-II2025-02-28
06970873260297Root Canal Instruments KitDY21-12022-02-19
06970873260013PULP TESTERDY3102022-02-19
06970873260051Endo Motor RCTI-DY(II)2022-02-19
06970873260068Endo Motor iMate-II2022-02-19

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 TipDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDEKR2026-09-24
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
00348783009132Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783009149Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-29
00348783008913Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008920Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008937Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28
00348783008944Premier PluggersPREMIER DENTAL PRODUCTS COMPANYEKR2026-04-28