PRO-KIT

GUDID 08800011279042

POINTIMPLANT Co., Ltd.

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

• Primary Device ID: 08800011279042
• NIH Device Record Key: ee566c8e-8909-49a8-b7ff-0640ce2faa4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO-KIT
• Version Model Number: PRO-KIT
• Company DUNS: 695333960
• Company Name: POINTIMPLANT Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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	08800011279042 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

[08800011279042]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-29
• Device Publish Date: 2025-05-21

Devices Manufactured by POINTIMPLANT Co., Ltd.

• 08800011264819 - Tissue Punch Drill: 2025-06-02
• 08800011264840 - Point Drill: 2025-06-02
• 08800011265571 - Ball Analog: 2025-06-02
• 08800011265588 - Initial Drill: 2025-06-02
• 08800011265762 - Vertical Anchor: 2025-06-02
• 08800011265823 - Initial Drill: 2025-06-02
• 08800011265830 - Initial Drill: 2025-06-02
• 08800011265847 - Initial Drill: 2025-06-02