Twist Drill (Non-stopper)

GUDID 08800070234884

Izenimplant Co., Ltd.

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 08800070234884
• NIH Device Record Key: bacd0e58-3f6a-42fe-ae3c-b67519a54bb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Twist Drill (Non-stopper)
• Version Model Number: TDN2F22L
• Company DUNS: 963328442
• Company Name: Izenimplant 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800070234884 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

[08800070234884]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-23
• Device Publish Date: 2024-09-13

On-Brand Devices [Twist Drill (Non-stopper)]

• 08800070235096: TDN3F46S
• 08800070235089: TDN3F36S
• 08800070235072: TDN3F27S
• 08800070235034: TDN3F46L
• 08800070235027: TDN3F36L
• 08800070235010: TDN3F27L
• 08800070234976: TDN3F41S
• 08800070234969: TDN3F30S
• 08800070234952: TDN2F22S
• 08800070234907: TDN3F41L
• 08800070234891: TDN3F30L
• 08800070234884: TDN2F22L