FDA.reportPublic FDA data

Integrated Endo System

Primary DI
06970873260389
Brand
Integrated Endo System
Company
DENJOY DENTAL CO.,LTD
Model
Meet Endo-II
Published
2025-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKRPlugger, Root Canal, Endodontic
EKXHandpiece, Direct Drive, Ac-Powered
ELCScaler, Ultrasonic
LQYLocator, Root Apex

Product Code Classifications#

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

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
16970873260386PackageGS14In Commercial Distribution
06970873260389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697087326038616970873260386
06970873260389069708732603896970873260389

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
529329650
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979865810007Integrated Endo SystemMeet Endo-II2026-03-31
06979865810014Gutta Percha CutterMeta Pack2026-03-31
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
06970873260075Endo Motor iMate-II(IM2C)2022-02-19
06970873260082Cordless Gutta percha obturation system DY-GP2022-02-19
06970873260112Endo Rotary file K file, Machine super file, Machine H file, G file2022-02-19
06970873260143Gutta percha obturation system DY-GP Plus2022-02-19
06970873260167Medical MicroscopeiX62022-02-19
06970873260174Medical MicroscopeiX72022-02-19
06970873260181Medical MicroscopeiX82022-02-19
06970873260198Endo Motor Ai Mate-I2022-02-19
06970873260259Endo Motor Ai Mate-II2022-02-19
06970873260266Endo Motor iMate 32022-02-19
06970873260280Medical Face ShieldDF-202022-02-19
06970873260303 Dental Suction UnitDY-CX012022-02-19
06970873260310Intraoral CameraOrdinary model, standard model, luxury model2022-02-19
06970873260327Pulp Canal ReamerVertical pressure needle2022-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353240950PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353257743AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353311803Instrument PI starter kitE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
08404535018981Brasseler USAPeter Brasseler Holdings, LLCEKR2026-06-26
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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