Extra EZ Post Abutment AREEN385045L

GUDID 08809931186102

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809931186102
• NIH Device Record Key: 56dec5c7-54ba-4a09-92a1-fc48adf9dcd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extra EZ Post Abutment
• Version Model Number: AREEN385045
• Catalog Number: AREEN385045L
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809931186102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110955

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

[08809931186102]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-07
• Device Publish Date: 2024-01-30

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• 08809931186119: AREEN385055
• 08809931186102: AREEN385045
• 08809931186096: AREEN385035
• 08809931186089: AREEN385025
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