ZENEX Slim KIT

GUDID 08800070237380

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08800070237380
• NIH Device Record Key: 0140d682-bf09-457d-9a69-558a217c0d28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENEX Slim KIT
• Version Model Number: ZENSLRKIT
• Company DUNS: 694625347
• 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: true
• 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	08800070237380 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

[08800070237380]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-23
• Device Publish Date: 2025-04-15

Devices Manufactured by Izenimplant Co., Ltd.

• 08800070237106 - ZENEX EASY SURGERY KIT: 2025-04-23
• 08800070237380 - ZENEX Slim KIT: 2025-04-23
• 08800070237380 - ZENEX Slim KIT: 2025-04-23
• 08800070230596 - ZENEX Guide Flattening Drill: 2025-01-14
• 08800070234747 - ZENEX Guide Flattening Drill: 2025-01-14
• 08800070234754 - ZENEX Guide Flattening Drill: 2025-01-14
• 08800070234761 - ZENEX Guide Flattening Drill: 2025-01-14
• 08800070234778 - ZENEX Guide Flattening Drill: 2025-01-14
• 08800070236833 - Bite Impression Coping Driver: 2024-12-20