Cover Screww

GUDID 08809917603111

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08809917603111
• NIH Device Record Key: de7e3e29-f8e3-4f23-ab49-2532a2a1d5c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cover Screww
• Version Model Number: CS2800M
• 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: true
• 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	08809917603111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240091

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-10
• Device Publish Date: 2024-05-02

Devices Manufactured by ARUM DENTISTRY Co., Ltd.

• 08800055715742 - Customized Abutment: 2024-07-02
• 08800055715759 - Customized Abutment: 2024-07-02
• 08800055715766 - Customized Abutment: 2024-07-02
• 08800055715773 - Customized Abutment: 2024-07-02
• 08800055715780 - Customized Abutment: 2024-07-02
• 08800055715797 - Customized Abutment: 2024-07-02
• 08800055721330 - Customized Abutment: 2024-07-02
• 08800055721347 - Customized Abutment: 2024-07-02