Integrated Endo System

GUDID 06970873260389

DENJOY DENTAL CO.,LTD

Endodontic obturation system

• Primary Device ID: 06970873260389
• NIH Device Record Key: eb99b5e7-8b28-4da2-a4bd-d1b01fb7a322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrated Endo System
• Version Model Number: Meet Endo-II
• Company DUNS: 529329650
• Company Name: DENJOY DENTAL CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970873260389 [Primary]
GS1	16970873260386 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242317

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

[06970873260389]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by DENJOY DENTAL CO.,LTD

• 06970873260389 - Integrated Endo System: 2025-03-10
• 06970873260389 - Integrated Endo System: 2025-03-10
• 06970873260013 - PULP TESTER: 2022-02-28
• 06970873260051 - Endo Motor: 2022-02-28
• 06970873260068 - Endo Motor: 2022-02-28
• 06970873260075 - Endo Motor: 2022-02-28
• 06970873260082 - Cordless Gutta percha obturation system: 2022-02-28
• 06970873260112 - Endo Rotary file: 2022-02-28 K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH
• 06970873260143 - Gutta percha obturation system: 2022-02-28