Fuse Abutment AOFAP5535P

GUDID 08806388208500

AnyOne Internal Implant System

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388208500
• NIH Device Record Key: c0f2bac2-bfbb-42f6-8fa1-d89d8574af81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fuse Abutment
• Version Model Number: AOFAP5535
• Catalog Number: AOFAP5535P
• 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	08806388208500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123988

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

[08806388208500]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [Fuse Abutment]

• 08806388204243: AnyRidge Internal Ø5/ Hex/ Milling
• 08806388208500: AnyOne Internal Implant System