CCM Abutment AROCCMNO4111T

GUDID 08806388260065

Ø4/ L=11/ Octa/ NC

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388260065
• NIH Device Record Key: 54fe45bb-d339-4219-9518-f21a49b83405
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCM Abutment
• Version Model Number: AROCCMNO4111
• Catalog Number: AROCCMNO4111T
• 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	08806388260065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182448

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806388260065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [CCM Abutment]

• 08806388211470: AnyOne Internal Ø4.5/ Non-Hex
• 08806388211463: AnyOne Internal Ø4.5/ Hex
• 08806388260096: Ø4/ L=11/ Non-Octa/ RC
• 08806388260089: Ø4/ L=11/ Octa/ RC
• 08806388260072: Ø4/ L=11/ Non-Octa/ NC
• 08806388260065: Ø4/ L=11/ Octa/ NC
• 08806388220359: Exfeel Internal Ø5.5/ L=12/ Octa
• 08806388220342: Exfeel Internal Ø5.5/ L=12/ Non-Octa
• 08806388201020: Ø4/ L=12/ Non-Hex
• 08806388201013: Ø4/ L=12/ Hex