AnyRidge Internal Fixture FALIHR6007C

GUDID 08806388216482

AnyRidge Internal Implant System

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806388216482
• NIH Device Record Key: b3359835-8b5e-4ba9-b5e4-342c25b3de3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyRidge Internal Fixture
• Version Model Number: FALIHR6007
• Catalog Number: FALIHR6007C
• 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: true
• 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	08806388216482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110955

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

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

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• 08806388216543: AnyRidge Internal Implant System
• 08806388216482: AnyRidge Internal Implant System