8plant Implant System

GUDID 08800096850778

8plant Implant Fixture

8dent Inc.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800096850778
• NIH Device Record Key: 05312fe3-9882-4c6f-bc1c-db5d3dc7f106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8plant Implant System
• Version Model Number: BM3508
• Company DUNS: 694477724
• Company Name: 8dent Inc.
• 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	08800096850778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231426

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: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [8plant Implant System]

• 08800096850778: 8plant Implant Fixture
• 08800096850792: 8plant Implant Fixture
• 08800096850785: 8plant Implant Fixture