FDA.reportPublic FDA data

JAS Unit Endo System

Primary DI
06979865810175
Brand
JAS Unit Endo System
Company
DENJOY DENTAL CO.,LTD
Model
JAS Unit
Device description
JAS Unit Endo System
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
EKRPlugger, Root Canal, Endodontic
EKXHandpiece, Direct Drive, Ac-Powered
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKRPlugger, Root Canal, EndodonticDental1
EKXHandpiece, Direct Drive, Ac-PoweredDental1
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242317000Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.2025-02-13ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979865810175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979865810175069798658101756979865810175

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation systemAn assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529329650
Device count
1
DM exempt
false
Premarket exempt
false
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
false
No natural rubber latex
false
Sterilization required before use
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
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
06979865810038JAS MotorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810038JAS MotorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDEKX2026-09-24
06979865810137JAS Heat Plugger TipDENJOY DENTAL CO.,LTDEKR2026-09-24
06979865810168JAS Pack Gutta-Percha CutterDENJOY DENTAL CO.,LTDEKR2026-09-24
06944843624365Ultrapro TX CordlessULTRADENT PRODUCTS, INC.EKX2026-09-19