Master Fix

GUDID 08800265643064

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800265643064
• NIH Device Record Key: 80e891aa-1267-42e2-9b41-39281c34df55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Master Fix
• Version Model Number: NBR_M5535TNP
• 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	08800265643064 [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

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

Moist Heat or Steam Sterilization

[08800265643064]

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]

• 08809924581853: SALN6555RP
• 08809924581846: SALN6545RP
• 08809924581839: SALN6535RP
• 08809924581822: SALN6525RP
• 08809924581815: SALN6515RP
• 08809924581808: SALN6553RP
• 08809924581792: SALN6543RP
• 08809924581785: SALN6533RP
• 08809924581778: SALN6523RP
• 08809924581761: SALN6513RP
• 08809924581754: SALN5555RP
• 08809924581747: SALN5545RP
• 08809924581730: SALN5535RP
• 08809924581723: SALN5525RP
• 08809924581716: SALN5515RP
• 08809924581709: SALN5553RP
• 08809924581693: SALN5543RP
• 08809924581686: SALN5533RP
• 08809924581679: SALN5523RP
• 08809924581662: SALN5513RP
• 08809924581655: SALN4555RP
• 08809924581648: SALN4545RP
• 08809924581631: SALN4535RP
• 08809924581624: SALN4525RP
• 08809924581617: SALN4515RP
• 08809924581600: SALN4553RP
• 08809924581594: SALN4543RP
• 08809924581587: SALN4533RP
• 08809924581570: SALN4523RP
• 08809924581563: SALN4513RP
• 08809924581556: SALH6555RP
• 08809924581549: SALH6545RP
• 08809924581532: SALH6535RP
• 08809924581525: SALH6525RP
• 08809924581518: SALH6515RP
• 08809924581501: SALH6553RP
• 08809924581495: SALH6543RP
• 08809924581488: SALH6533RP
• 08809924581471: SALH6523RP
• 08809924581464: SALH6513RP
• 08809924581457: SALH5555RP
• 08809924581440: SALH5545RP
• 08809924581433: SALH5535RP
• 08809924581426: SALH5525RP
• 08809924581419: SALH5515RP
• 08809924581402: SALH5553RP
• 08809924581396: SALH5543RP
• 08809924581389: SALH5533RP
• 08809924581372: SALH5523RP
• 08809924581365: SALH5513RP