NB Fixture Mini

GUDID 08800055751283

ARUM DENTISTRY Co., Ltd.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800055751283
• NIH Device Record Key: 6542805a-7454-4960-8ccc-8937e0a56621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NB Fixture Mini
• Version Model Number: NB3511SP
• 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	08800055751283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240091

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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 [NB Fixture Mini ]

• 08809924580788: NB3513SS
• 08809917609786: NB3513SP
• 08809917609779: NB3511SS
• 08809917609762: NB3510SS
• 08809917609755: NB3508SS
• 08809917609748: NB3213SS
• 08809917609731: NB3211SS
• 08809917609724: NB3210SS
• 08809917609717: NB3208SS
• 08800055751283: NB3511SP
• 08800055751276: NB3510SP
• 08800055751269: NB3508SP
• 08800055751252: NB3213SP
• 08800055751245: NB3211SP
• 08800055751238: NB3210SP
• 08800055751221: NB3208SP