Flat Plastic cylinder FPC4012T

GUDID 08806388219490

AnyOne Internal Ø4/ L=12

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388219490
• NIH Device Record Key: 525af839-1b74-4d56-aa43-a03324e1f8d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flat Plastic cylinder
• Version Model Number: FPC4012
• Catalog Number: FPC4012T
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	08806388219490 [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

[08806388219490]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-06-24

Devices Manufactured by Megagen Implant Co. Ltd

• 08809985669873 - AXA Prosthetic Kit: 2024-12-12 XPEED AnyRidge Internal Implant System
• 08809708757597 - TiGEN Abutment: 2024-12-09
• 08809708757603 - TiGEN Abutment: 2024-12-09
• 08809708758334 - TiGEN Abutment: 2024-12-09
• 08809708758341 - TiGEN Abutment: 2024-12-09
• 08809822764617 - TiGEN Abutment: 2024-12-09
• 08809822764624 - TiGEN Abutment: 2024-12-09
• 08809822764631 - TiGEN Abutment: 2024-12-09