Cordless Gutta percha obturation system

GUDID 06970873260082

DENJOY DENTAL CO.,LTD

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• Primary Device ID: 06970873260082
• NIH Device Record Key: 62e2b2f7-97ac-4c56-818b-59ae4b11f0f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cordless Gutta percha obturation system
• Version Model Number: DY-GP
• Company DUNS: 529329650
• Company Name: DENJOY DENTAL CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970873260082 [Primary]

FDA Product Code

• EKR: Plugger, Root Canal, Endodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-19

Devices Manufactured by DENJOY DENTAL CO.,LTD

• 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
• 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
• 06970873260167 - Medical Microscope: 2022-02-28