Octa Abutment OA5055

GUDID 08806388229963

AnyOne Internal Ø4.8/ C=5.5

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806388229963
• NIH Device Record Key: e2147d72-e972-4dc8-a059-7c89f93c25ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Octa Abutment
• Version Model Number: OA5055
• Catalog Number: OA5055
• 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	08806388229963 [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

[08806388229963]

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: 2015-06-23

On-Brand Devices [Octa Abutment]

• 08806388230020: AnyOne Internal Ø5.8/ C=5.5
• 08806388230013: AnyOne Internal Ø5.8/ C=4.5
• 08806388230006: AnyOne Internal Ø5.8/ C=3.5
• 08806388229994: AnyOne Internal Ø5.8/ C=2.5
• 08806388229987: AnyOne Internal Ø5.8/ C=1.5
• 08806388229970: AnyOne Internal Ø5.8/ C=1
• 08806388229963: AnyOne Internal Ø4.8/ C=5.5
• 08806388229956: AnyOne Internal Ø4.8/ C=4.5
• 08806388229949: AnyOne Internal Ø4.8/ C=3.5
• 08806388229932: AnyOne Internal Ø4.8/ C=2.5
• 08806388229925: AnyOne Internal Ø4.8/ C=1.5
• 08806388229918: AnyOne Internal Ø4.8/ C=1
• 08806388229901: AnyOne Internal Ø3.8/ C=5.5
• 08806388229895: AnyOne Internal Ø3.8/ C=4.5
• 08806388229888: AnyOne Internal Ø3.8/ C=3.5
• 08806388229871: AnyOne Internal Ø3.8/ C=2.5
• 08806388229864: AnyOne Internal Ø3.8/ C=1.5
• 08806388229857: AnyOne Internal Ø3.8/ C=1
• 08806388203314: AnyRidge Internal Ø4.8/ C=5
• 08806388203307: AnyRidge Internal Ø4.8/ C=4
• 08806388203291: AnyRidge Internal Ø4.8/ C=3
• 08806388203284: AnyRidge Internal Ø4.8/ C=2
• 08806388222063: Exfeel Internal Octa