NB Cemented Abutment Screw

GUDID 08800055724294

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800055724294
• NIH Device Record Key: ee9005fa-60a1-440c-8457-6522383d63ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NB Cemented Abutment Screw
• Version Model Number: NBAS
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	08800055724294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213506

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

[08800055724294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-10

Devices Manufactured by ARUM DENTISTRY Co., Ltd.

• 08809917605139 - NB I Fixture: 2025-01-30
• 08800055722054 - Ti-Base: 2025-01-28
• 08800055726960 - Angled Abutment Mini: 2025-01-28
• 08800055742687 - Healing Abutment: 2025-01-28
• 08800055742694 - Healing Abutment: 2025-01-28
• 08800055742700 - Healing Abutment: 2025-01-28
• 08800055742717 - Healing Abutment: 2025-01-28
• 08800055742724 - Healing Abutment: 2025-01-28