8plant

GUDID 08800096851683

8dent Inc.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800096851683
• NIH Device Record Key: 0f4730af-0f56-49a4-a7b7-295b4046caba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8plant
• Version Model Number: ASM3508N
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr
• Phone: +82517147240
• Email: info@8dent.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800096851683 [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: 2025-07-17
• Device Publish Date: 2025-07-09

Devices Manufactured by 8dent Inc.

• 08800096850785 - 8plant Implant System: 2026-04-01 8plant Implant Fixture
• 08800096850792 - 8plant Implant System: 2026-04-01 8plant Implant Fixture
• 08800096850778 - 8plant Implant System: 2026-03-31 8plant Implant Fixture
• 08800096851683 - 8plant: 2025-07-17
• 08800096851683 - 8plant: 2025-07-17