ExFeel Internal Fixture ISDB4108E

GUDID 08806388222605

ExFeel Internal

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806388222605
• NIH Device Record Key: 4d87b693-cb42-45e6-bde1-8244a2e13eed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExFeel Internal Fixture
• Version Model Number: ISDB4108E
• Catalog Number: ISDB4108E
• 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: 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	08806388222605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052369

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: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [ExFeel Internal Fixture]

• 08809728991605: ExFeel Internal
• 08809728991599: ExFeel Internal
• 08809728991582: ExFeel Internal
• 08809728991575: ExFeel Internal
• 08809728991568: ExFeel Internal
• 08809728991551: ExFeel Internal
• 08809728991544: ExFeel Internal
• 08809728991537: ExFeel Internal
• 08809728991520: ExFeel Internal
• 08809728991513: ExFeel Internal
• 08809728991506: ExFeel Internal
• 08809728991490: ExFeel Internal
• 08809728991483: ExFeel Internal
• 08809728991476: EX
• 08809728991469: EX
• 08806388222957: ExFeel Internal
• 08806388222940: ExFeel Internal
• 08806388222889: ExFeel Internal
• 08806388222841: ExFeel Internal
• 08806388222803: ExFeel Internal
• 08806388222766: ExFeel Internal
• 08806388222728: ExFeel Internal
• 08806388222681: ExFeel Internal
• 08806388222643: ExFeel Internal
• 08806388222605: ExFeel Internal
• 08806388222575: ExFeel Internal
• 08806388222568: ExFeel Internal