Master Fix Screw

GUDID 08800265641770

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800265641770
• NIH Device Record Key: db204ff3-f3ef-4575-88d7-957beb4d726a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Master Fix Screw
• Version Model Number: NBR_MS45T
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800265641770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240603

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

[08800265641770]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-28
• Device Publish Date: 2025-01-20

On-Brand Devices [Master Fix Screw]

• 08809924581952: NBLS55R
• 08809924581945: NBLS45R
• 08809924581938: NBLS35R
• 08809924581921: NBLS25R
• 08809924581914: NBLS15R
• 08809924581907: NBLS53R
• 08809924581891: NBLS43R
• 08809924581884: NBLS33R
• 08809924581877: NBLS23R
• 08809924581860: NBLS13R
• 08800265641787: NBR_MS55T
• 08800265641770: NBR_MS45T
• 08800265641763: NBR_MS35T
• 08800265641756: NBR_MS25T
• 08800265641749: NBR_MS15T