FDA.reportPublic FDA data

JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter

Primary DI
06979865810151
Brand
JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter
Company
DENJOY DENTAL CO.,LTD
Model
JAS Kit
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NYDEndodontic Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYDEndodontic KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979865810151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979865810151069798658101516979865810151

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

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
06979865810168JAS Pack Gutta-Percha CutterJAS Pack2026-09-24
06979865810175JAS Unit Endo SystemJAS Unit2026-09-24
06979865810007Integrated Endo SystemMeet Endo-II2026-03-31
06979865810014Gutta Percha CutterMeta Pack2026-03-31
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
00887919921608Brasseler USAPeter Brasseler Holdings, LLCNYD2023-01-25
00850001745628Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2022-08-22
00850001745635Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2022-08-22
M75240473APP0STRADIS HEALTHCARESTRADIS MEDICAL, LLCNYD2022-03-21
00850001745000Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
00850001745017Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
00085000174500Dental Engineering Lab-TFRKDENTAL ENGINEERING LABORATORIES, LLCNYD2018-10-08
M75240473APP1STRADISSTRADIS MEDICAL, LLCNYD2016-05-05