Temporary Cylinder AXTCS504CT

GUDID 08809985656729

Common

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809985656729
• NIH Device Record Key: e716ba32-bfb9-47a0-aebf-7f1f0d1876c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temporary Cylinder
• Version Model Number: AXTCS504C
• Catalog Number: AXTCS504CT
• 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	08809985656729 [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

[08809985656729]

Moist Heat or Steam Sterilization

[08809985656729]

Moist Heat or Steam Sterilization

[08809985656729]

Moist Heat or Steam Sterilization

[08809985656729]

Moist Heat or Steam Sterilization

[08809985656729]

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 [Temporary Cylinder]

• 08806388203512: AnyRidge Internal Ø5.8/ Octa
• 08806388203505: AnyRidge Internal Ø4.8/ Octa
• 08806388203499: AnyRidge Internal Ø3.8/ Octa
• 08806388203482: AnyRidge Internal Ø5.8/ Non-Octa
• 08806388203475: AnyRidge Internal Ø4.8/ Non-Octa
• 08806388203468: AnyRidge Internal Ø3.8/ Non-Octa
• 08806388244102: Ø4.8 / L=10
• 08809985656736: Common
• 08809985656729: Common
• 08809985656712: Common
• 08809985653469: Common
• 08809985653452: Common
• 08809977450496: Common
• 08809977450489: Common
• 08809977450472: Common
• 08809977450465: Common