Biotem Bone Pen Air Kit

GUDID 08800036261350

Biotem Co., ltd

Dental implant system

• Primary Device ID: 08800036261350
• NIH Device Record Key: e4206242-cc0a-4711-9fd5-0fe66fb075d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotem Bone Pen Air Kit
• Version Model Number: BPAK
• Company DUNS: 557793214
• Company Name: Biotem Co., ltd
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800036261350 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

[08800036261350]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-26
• Device Publish Date: 2025-08-18

Devices Manufactured by Biotem Co., ltd

• 08800036261237 - Bone Pen Drill: 2025-08-26
• 08800036261244 - Bone Pen Drill: 2025-08-26
• 08800036261251 - Bone Pin: 2025-08-26
• 08800036261268 - Bone Pin: 2025-08-26
• 08800036261275 - Bone Pin: 2025-08-26
• 08800036261282 - Bone Pin: 2025-08-26
• 08800036261299 - Bone Pin: 2025-08-26
• 08800036261305 - Bone Cup: 2025-08-26