CCM Cylinder AXCCM504ST

GUDID 08800293004301

Ø5/ H=4/ Single

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800293004301
• NIH Device Record Key: 94b540b4-de9a-440b-b5c2-f49b9fa6fe3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCM Cylinder
• Version Model Number: AXCCM504S
• Catalog Number: AXCCM504ST
• 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	08800293004301 [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

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

[08800293004301]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-21
• Device Publish Date: 2025-05-13

On-Brand Devices [CCM Cylinder]

• 08806388218073: AnyOne Internal Ø4/ L=12
• 08806388201204: AnyRidge Internal Ø5.8/ Octa
• 08806388201198: AnyRidge Internal Ø4.8/ Octa
• 08806388201181: AnyRidge Internal Ø3.8/ Octa
• 08806388201174: AnyRidge Internal Ø5.8/ Non-Octa
• 08806388201167: AnyRidge Internal Ø4.8/ Non-Octa
• 08806388201150: AnyRidge Internal Ø3.8/ Non-Octa
• 08806388244010: Ø4.8 / L=13
• 08800293004301: Ø5/ H=4/ Single
• 08800293004295: Ø5/ H=4