Abutment Screw

GUDID 08800055721385

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800055721385
• NIH Device Record Key: 0b676269-23ff-46e1-840b-3773484e2ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abutment Screw
• Version Model Number: CSTO601
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800055721385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234112

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

[08800055721385]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07

On-Brand Devices [Abutment Screw]

• 08809917602268: NBMAS
• 08800055796406: NBAS
• 08800055721392: CSTO602
• 08800055721385: CSTO601
• 08800055717791: CSHE016