AXA Abutment AXBDNS54620T

GUDID 08809985661112

BLUEDIAMOND

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809985661112
• NIH Device Record Key: 96e01e43-3648-43cb-a12a-8eda48323dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXA Abutment
• Version Model Number: AXBDNS54620
• Catalog Number: AXBDNS54620T
• Company DUNS: 687388178
• Company Name: Megagen Implant 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: true
• 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	08809985661112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233450

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

[08809985661112]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [AXA Abutment]

• 08809985661389: BLUEDIAMOND
• 08809985661372: BLUEDIAMOND
• 08809985661365: BLUEDIAMOND
• 08809985661358: BLUEDIAMOND
• 08809985661341: BLUEDIAMOND
• 08809985661334: BLUEDIAMOND
• 08809985661327: BLUEDIAMOND
• 08809985661228: BLUEDIAMOND
• 08809985661204: BLUEDIAMOND
• 08809985661181: BLUEDIAMOND
• 08809985661167: BLUEDIAMOND
• 08809985661143: BLUEDIAMOND
• 08809985661129: BLUEDIAMOND
• 08809985661105: BLUEDIAMOND
• 08809985661082: BLUEDIAMOND
• 08809985661068: BLUEDIAMOND
• 08809985661044: BLUEDIAMOND
• 08809985661020: BLUEDIAMOND
• 08809985661006: BLUEDIAMOND
• 08809985660986: BLUEDIAMOND
• 08809985660962: BLUEDIAMOND
• 08809985660887: BLUEDIAMOND
• 08809985660870: BLUEDIAMOND
• 08809985660863: BLUEDIAMOND
• 08809985660856: BLUEDIAMOND
• 08809985660849: BLUEDIAMOND
• 08809985660832: BLUEDIAMOND
• 08809985660825: AXBDNS52400
• 08809985661815: BLUEDIAMOND
• 08809985661808: BLUEDIAMOND
• 08809985661792: BLUEDIAMOND
• 08809985661785: BLUEDIAMOND
• 08809985661778: BLUEDIAMOND
• 08809985661761: BLUEDIAMOND
• 08809985661754: BLUEDIAMOND
• 08809985661747: BLUEDIAMOND
• 08809985661730: BLUEDIAMOND
• 08809985661723: BLUEDIAMOND
• 08809985661716: BLUEDIAMOND
• 08809985661709: BLUEDIAMOND
• 08809985661693: BLUEDIAMOND
• 08809985661686: BLUEDIAMOND
• 08809985661679: BLUEDIAMOND
• 08809985661662: BLUEDIAMOND
• 08809985661655: BLUEDIAMOND
• 08809985661648: BLUEDIAMOND
• 08809985661631: BLUEDIAMOND
• 08809985661624: BLUEDIAMOND
• 08809985661617: BLUEDIAMOND
• 08809985661600: BLUEDIAMOND