Cover Screw

GUDID 08809917603197

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08809917603197
• NIH Device Record Key: 5f610a24-1ff7-403a-bae3-ba20532fb64b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cover Screw
• Version Model Number: CS2800GM
• 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	08809917603197 [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: 2024-05-13
• Device Publish Date: 2024-05-03

On-Brand Devices [Cover Screw]

• 08809917603265: CS3403GR
• 08809917603258: CS3402GR
• 08809917603241: CS3401GR
• 08809917603234: CS3400GR
• 08809917603227: CS2803GM
• 08809917603210: CS2802GM
• 08809917603203: CS2801GM
• 08809917603197: CS2800GM
• 08809917603180: CS3403R
• 08809917603173: CS3402R
• 08809917603166: CS3401R
• 08809917603159: CS3400R
• 08809917603142: CS2803M
• 08809917603135: CS2802M
• 08809917603128: CS2801M