Healing Cap AXHC402T

GUDID 08809985653476

Common

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809985653476
• NIH Device Record Key: d7de21c4-ad27-41ef-9aa0-4cea561bd511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Cap
• Version Model Number: AXHC402
• Catalog Number: AXHC402T
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	08809985653476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233450

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809985653476]

Moist Heat or Steam Sterilization

[08809985653476]

Moist Heat or Steam Sterilization

[08809985653476]

Moist Heat or Steam Sterilization

[08809985653476]

Moist Heat or Steam Sterilization

[08809985653476]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

On-Brand Devices [Healing Cap]

• 08806388233038: ExFeel External Standard
• 08806388232925: Rescue External Widecone
• 08806388232451: ExFeel External Esthetic type
• 08806388221783: ExFeel Internal Ø5
• 08806388203437: AnyRidge Internal Ø5.8
• 08806388203420: AnyRidge Internal Ø3.8
• 08806388244546: Ø4.9/ Wide
• 08806388244539: Ø4.9/ Regular
• 08809985656798: Common
• 08809985656781: Common
• 08809985656774: Common
• 08809985653537: Common
• 08809985653520: Common
• 08809985653513: Common
• 08809985653506: Common
• 08809985653490: Common
• 08809985653483: Common
• 08809985653476: Common
• 08809977451806: Common
• 08809977450885: Common
• 08809977450878: Common
• 08809977450861: Common
• 08809977450854: Common
• 08809977450847: Common
• 08809977450830: Common
• 08809977450823: Common
• 08809977450816: Common
• 08809977450809: Common
• 08809977450793: Common
• 08809985666308: Ø5/ H=4/ Single