AnyOne Internal Fixture IF5507DXAC

GUDID 08809822768097

AnyOne Internal Implant System (C4.6) Ø5.5/ L7.0

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809822768097
• NIH Device Record Key: beed8931-63e8-4c83-8fe7-8f5ec2edaa9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyOne Internal Fixture
• Version Model Number: IF5507D
• Catalog Number: IF5507DXAC
• 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: true
• 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	08809822768097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123988

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [AnyOne Internal Fixture]

• 08809822768202: AnyOne Internal Implant System (C6.6) Ø8.0/ L7.0
• 08809822768196: AnyOne Internal Implant System (C6.6) Ø8.0/ L8.5
• 08809822768189: AnyOne Internal Implant System (C6.6) Ø8.0/ L10.0
• 08809822768172: AnyOne Internal Implant System (C6.6) Ø8.0/ L11.5
• 08809822768165: AnyOne Internal Implant System (C6.6) Ø8.0/ L13.0
• 08809822767984: AnyOne Internal Implant System (C6.6) Ø7.5/ L7.0
• 08809822767977: AnyOne Internal Implant System (C6.6) Ø7.5/ L8.5
• 08809822767960: AnyOne Internal Implant System (C6.6) Ø7.5/ L10.0
• 08809822767953: AnyOne Internal Implant System (C6.6) Ø7.5/ L11.5
• 08809822767946: AnyOne Internal Implant System (C6.6) Ø7.5/ L13.0
• 08809822767922: AnyOne Internal Implant System (C6.6) Ø7.0/ L15.0
• 08809822767908: AnyOne Internal Implant System (C6.6) Ø7.5/ L15.0
• 08809822767892: AnyOne Internal Implant System (C6.6) Ø8.0/ L15.0
• 08809822768448: AnyOne Internal Implant System (C3.6) Ø4.0/ L15.0
• 08809822768424: AnyOne Internal Implant System (C4.1) Ø4.5/ L7.0
• 08809822768417: AnyOne Internal Implant System (C4.1) Ø4.5/ L8.5
• 08809822768400: AnyOne Internal Implant System (C4.1) Ø4.5/ L10.0
• 08809822768394: AnyOne Internal Implant System (C4.1) Ø4.5/ L11.5
• 08809822768387: AnyOne Internal Implant System (C4.1) Ø4.5/ L13.0
• 08809822768370: AnyOne Internal Implant System (C4.1) Ø4.5/ L15.0
• 08809822768363: AnyOne Internal Implant System (C4.6) Ø5.0/ L7.0
• 08809822768356: AnyOne Internal Implant System (C4.6) Ø5.0/ L8.5
• 08809822768349: AnyOne Internal Implant System (C4.6) Ø5.0/ L10.0
• 08809822768332: AnyOne Internal Implant System (C4.6) Ø5.0/ L11.5
• 08809822768325: AnyOne Internal Implant System (C4.6) Ø5.0/ L13.0
• 08809822768318: AnyOne Internal Implant System (C4.6) Ø5.0/ L15.0
• 08809822768301: AnyOne Internal Implant System (C5.6) Ø6.0/ L7.0
• 08809822768295: AnyOne Internal Implant System (C5.6) Ø6.0/ L8.5
• 08809822768288: AnyOne Internal Implant System (C5.6) Ø6.0/ L10.0
• 08809822768271: AnyOne Internal Implant System (C5.6) Ø6.0/ L11.5
• 08809822768264: AnyOne Internal Implant System (C5.6) Ø6.0/ L13.0
• 08809822768257: AnyOne Internal Implant System (C6.6) Ø7.0/ L7.0
• 08809822768240: AnyOne Internal Implant System (C6.6) Ø7.0/ L8.5
• 08809822768233: AnyOne Internal Implant System (C6.6) Ø7.0/ L10.0
• 08809822768226: AnyOne Internal Implant System (C6.6) Ø7.0/ L11.5
• 08809822768219: AnyOne Internal Implant System (C6.6) Ø7.0/ L13.0
• 08809822768158: AnyOne Internal Implant System (C3.6) Ø4.5/ L7.0
• 08809822768141: AnyOne Internal Implant System (C3.6) Ø4.5/ L8.5
• 08809822768134: AnyOne Internal Implant System (C3.6) Ø4.5/ L10.0
• 08809822768127: AnyOne Internal Implant System (C3.6) Ø4.5/ L11.5
• 08809822768110: AnyOne Internal Implant System (C3.6) Ø4.5/ L13.0
• 08809822768103: AnyOne Internal Implant System (C3.6) Ø4.5/ L15.0
• 08809822768097: AnyOne Internal Implant System (C4.6) Ø5.5/ L7.0
• 08809822768080: AnyOne Internal Implant System (C4.6) Ø5.5/ L8.5
• 08809822768073: AnyOne Internal Implant System (C4.6) Ø5.5/ L10.0
• 08809822768066: AnyOne Internal Implant System (C4.6) Ø5.5/ L11.5
• 08809822768059: AnyOne Internal Implant System (C4.6) Ø5.5/ L13.0
• 08809822768042: AnyOne Internal Implant System (C4.6) Ø5.5/ L15.0
• 08809822768035: AnyOne Internal Implant System (C5.6) Ø6.5/ L7.0
• 08809822768028: AnyOne Internal Implant System (C5.6) Ø6.5/ L8.5