BLUEDIAMOND IMPLANT ARO4815DXAC

GUDID 08809822769247

BLUEDIAMOND Implant System (C4.2) Ø4.8/ L15.0

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08809822769247
• NIH Device Record Key: 764e5d42-bd33-4924-80e1-76d417e6f95e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUEDIAMOND IMPLANT
• Version Model Number: ARO4815D
• Catalog Number: ARO4815DXAC
• 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	08809822769247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182448

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: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [BLUEDIAMOND IMPLANT]

• 08809822769803: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L18.0
• 08809822769797: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L7.0
• 08809822769780: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L8.5
• 08809822769773: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L10.0
• 08809822769766: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L11.5
• 08809822769759: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L13.0
• 08809822769674: BLUEDIAMOND Implant System (C3.8) Ø4.4/ L15.0
• 08809822769667: BLUEDIAMOND Implant System (C3.8) Ø4.4/ L18.0
• 08809822769650: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L7.0
• 08809822769643: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L8.5
• 08809822769636: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L10.0
• 08809822769629: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L11.5
• 08809822769612: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L13.0
• 08809822769605: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L15.0
• 08809822769582: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L18.0
• 08809822769452: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L18.0
• 08809822769445: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L7.0
• 08809822769438: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L8.5
• 08809822769421: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L10.0
• 08809822769414: BLUEDIAMOND Implant System (C3.5) Ø4.1/ L11.5
• 08809822769339: BLUEDIAMOND Implant System (C3.8) Ø4.4/ L13.0
• 08809822769315: BLUEDIAMOND Implant System (C3.8) Ø4.4/ L15.0
• 08809822769308: BLUEDIAMOND Implant System (C3.8) Ø4.4/ L18.0
• 08809822769292: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L7.0
• 08809822769285: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L8.5
• 08809822769278: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L10.0
• 08809822769261: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L11.5
• 08809822769254: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L13.0
• 08809822769247: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L15.0
• 08809822769230: BLUEDIAMOND Implant System (C4.2) Ø4.8/ L18.0
• 08809822769933: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L7.0
• 08809822769926: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L8.5
• 08809822769919: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L10.0
• 08809822769902: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L11.5
• 08809822769896: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L13.0
• 08809822769889: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L15.0
• 08809822769872: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L18.0
• 08809822769865: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L7.0
• 08809822769858: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L8.5
• 08809822769841: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L10.0
• 08809822769834: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L11.5
• 08809822769827: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L13.0
• 08809822769810: BLUEDIAMOND Implant System (C3.2) Ø3.7/ L15.0
• 08809822769599: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L11.5
• 08809822769575: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L8.5
• 08809822769568: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L7.0
• 08809822769551: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L10.0
• 08809822769544: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L13.0
• 08809822769537: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L15.0
• 08809822769520: BLUEDIAMOND Implant System (C2.8) Ø3.3/ L18.0