Oral retractor

GUDID 06970873260334

DENJOY DENTAL CO.,LTD

Hand-held dental retractor

• Primary Device ID: 06970873260334
• NIH Device Record Key: 8faa2fc6-d61c-43df-a3a4-a8d837d58b9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral retractor
• Version Model Number: DY20-1,DY20-2
• 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: true
• Serial Number: false
• 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	06970873260334 [Primary]

FDA Product Code

• EIF: Accessories, Retractor, Dental

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

• 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