ARUM NB Cover Screw

GUDID 08800055742564

ARUM DENTISTRY Co., Ltd.

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• Primary Device ID: 08800055742564
• NIH Device Record Key: 357957b3-1403-40c0-aaf0-d0ba6440b8e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARUM NB Cover Screw
• Version Model Number: CS3400R
• 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: 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	08800055742564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213506

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: 2022-06-21
• Device Publish Date: 2022-06-10

On-Brand Devices [ARUM NB Cover Screw]

• 08800055742670: CS3403GR
• 08800055742663: CS3402GR
• 08800055742656: CS3401GR
• 08800055742649: CS3400GR
• 08800055742595: CS3403R
• 08800055742588: CS3402R
• 08800055742571: CS3401R
• 08800055742564: CS3400R
• 08800055724300: NBCS