Mount Screw TMFS002

GUDID 08809708751427

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08809708751427
• NIH Device Record Key: d73361c6-3733-46ee-84f9-2ff05e73a397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mount Screw
• Version Model Number: TMFS002
• Catalog Number: TMFS002
• 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	08809708751427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052369

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

[08809708751427]

Moist Heat or Steam Sterilization

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 [Mount Screw]

• 08806388236534: ExFeel External L=12/ Small
• 08806388236527: ExFeel External L=2/ Small
• 08806388233311: Rescue External L=13.5
• 08809708751427: TMFS002