SD BL Fixture

GUDID 08800293192374

ARUM DENTISTRY Co., Ltd.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800293192374
• NIH Device Record Key: ffaf7254-67fe-40c5-b246-42be99f3e210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SD BL Fixture
• Version Model Number: B6008W
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800293192374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250280

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: 2026-01-19
• Device Publish Date: 2026-01-09

On-Brand Devices [SD BL Fixture]

• 08800293192398: B6011W
• 08800293192381: B6010W
• 08800293192374: B6008W
• 08800293192367: B6007W