ST Internal Fixture ST4011DC

GUDID 08809985651205

ST Internal Implant System

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08809985651205
• NIH Device Record Key: c3330c43-4c88-478c-84dd-d8d5f0c127ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ST Internal Fixture
• Version Model Number: ST4011D
• Catalog Number: ST4011DC
• 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	08809985651205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192347

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: 2024-09-30
• Device Publish Date: 2024-09-20

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