Point Drill

GUDID 08800070236901

Izenimplant Co., Ltd.

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 08800070236901
• NIH Device Record Key: 6c415bc5-1717-4a58-99a3-328d7f78a457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Point Drill
• Version Model Number: PDN3F20S
• 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	08800070236901 [Primary]

FDA Product Code

• DZA: Drill, Dental, Intraoral

Sterilization

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

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

[08800070236901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

On-Brand Devices [Point Drill]

• 08800070236901: PDN3F20S
• 08800070236895: PDN3F20L
• 08800070236888: PDS3F20S
• 08800070236871: PDS3F20L