XPEED AnyRidge Internal Fixture AR435508XAC

GUDID 08809822766659

XPEED AnyRidge Internal Implant System (C4.3) Ø5.5/ L8.5

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809822766659
• NIH Device Record Key: da7594cc-9ef6-45fa-bafd-a7f685571978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPEED AnyRidge Internal Fixture
• Version Model Number: AR435508
• Catalog Number: AR435508XAC
• 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	08809822766659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140091

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: 2023-06-07
• Device Publish Date: 2023-05-30

On-Brand Devices [XPEED AnyRidge Internal Fixture]

• 08806388262472: AnyRidge Internal (C4.8) Ø5.5/ L15.0
• 08806388262465: AnyRidge Internal (C4.8) Ø5.5/ L13.0
• 08806388262458: AnyRidge Internal (C4.8) Ø5.5/ L11.5
• 08806388262441: AnyRidge Internal (C4.8) Ø5.5/ L10.0
• 08806388262434: AnyRidge Internal (C4.8) Ø5.5/ L8.5
• 08806388262427: AnyRidge Internal (C4.8) Ø5.5/ L7.0
• 08806388262403: AnyRidge Internal (C4.3) Ø6.0/ L15.0
• 08806388262397: AnyRidge Internal (C4.3) Ø6.0/ L13.0
• 08806388262380: AnyRidge Internal (C4.3) Ø6.0/ L11.5
• 08806388262373: AnyRidge Internal (C4.3) Ø6.0/ L10.0
• 08806388262366: AnyRidge Internal (C4.3) Ø6.0/ L8.5
• 08806388262359: AnyRidge Internal (C4.3) Ø6.0/ L7.0
• 08806388262342: AnyRidge Internal (C4.3) Ø5.5/ L18.0
• 08806388262335: AnyRidge Internal (C4.3) Ø5.5/ L15.0
• 08806388262328: AnyRidge Internal (C4.3) Ø5.5/ L13.0
• 08806388262311: AnyRidge Internal (C4.3) Ø5.5/ L11.5
• 08806388262304: AnyRidge Internal (C4.3) Ø5.5/ L10.0
• 08806388262298: AnyRidge Internal (C4.3) Ø5.5/ L8.5
• 08806388262281: AnyRidge Internal (C4.3) Ø5.5/ L7.0
• 08806388262274: AnyRidge Internal (C4.3) Ø5.0/ L18.0
• 08806388262267: AnyRidge Internal (C4.3) Ø5.0/ L15.0
• 08806388262250: AnyRidge Internal (C4.3) Ø5.0/ L13.0
• 08806388262243: AnyRidge Internal (C4.3) Ø5.0/ L11.5
• 08806388262236: AnyRidge Internal (C4.3) Ø5.0/ L10.0
• 08806388262229: AR435008
• 08806388262212: AnyRidge Internal (C4.3) Ø5.0/ L7.0
• 08806388262199: AnyRidge Internal (C4.0) Ø6.0/ L15.0
• 08806388262182: AnyRidge Internal (C4.0) Ø6.0/ L13.0
• 08806388262175: AnyRidge Internal (C4.0) Ø6.0/ L11.5
• 08806388262168: AnyRidge Internal (C4.0) Ø6.0/ L10.0
• 08806388262151: AnyRidge Internal (C4.0) Ø6.0/ L8.5
• 08806388262144: AnyRidge Internal (C4.0) Ø6.0/ L7.0
• 08806388262137: AnyRidge Internal (C3.8) Ø5.5/ L18.0
• 08806388262120: AnyRidge Internal (C3.8) Ø5.5/ L15.0
• 08806388262113: AnyRidge Internal (C3.8) Ø5.5/ L13.0
• 08806388262106: AnyRidge Internal (C3.8) Ø5.5/ L11.5
• 08806388262090: AnyRidge Internal (C3.8) Ø5.5/ L10.0
• 08806388262083: AnyRidge Internal (C3.8) Ø5.5/ L8.5
• 08806388262076: AnyRidge Internal (C3.8) Ø5.5/ L7.0
• 08806388262069: AnyRidge Internal (C3.8) Ø5.0/ L18.0
• 08806388262052: AnyRidge Internal (C3.8) Ø5.0/ L15.0
• 08806388262045: AnyRidge Internal (C3.8) Ø5.0/ L13.0
• 08806388262038: AnyRidge Internal (C3.8) Ø5.0/ L11.5
• 08806388262021: AnyRidge Internal (C3.8) Ø5.0/ L10.0
• 08806388262014: AnyRidge Internal (C3.8) Ø5.0/ L8.5
• 08806388262007: AnyRidge Internal (C3.8) Ø5.0/ L7.0
• 08806388261994: AnyRidge Internal (C3.8) Ø4.5/ L18.0
• 08806388261987: AnyRidge Internal (C3.8) Ø4.5/ L15.0
• 08806388261970: AnyRidge Internal (C3.8) Ø4.5/ L13.0
• 08806388261963: AnyRidge Internal (C3.8) Ø4.5/ L11.5