SD TL Fixture

GUDID 08800293192114

ARUM DENTISTRY Co., Ltd.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800293192114
• NIH Device Record Key: b2544f10-0804-4fbf-8179-b750cdd17a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SD TL Fixture
• Version Model Number: T5008R
• 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	08800293192114 [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 TL Fixture]

• 08800293192084: T4511R
• 08800293192077: T4510R
• 08800293192060: T4508R
• 08800293192053: T4507R
• 08800293192046: T4013R
• 08800293192039: T4011R
• 08800293192022: T4010R
• 08800293192015: T4008R
• 08800293192008: T4007R
• 08800293191995: T3613R
• 08800293191988: T3611R
• 08800293191971: T3610R
• 08800293191964: T3608R
• 08800293191957: T3607R
• 08800293192343: T5013L
• 08800293192336: T5011L
• 08800293192329: T5010L
• 08800293192312: T5008L
• 08800293192305: T5007L
• 08800293192299: T4513L
• 08800293192282: T4511L
• 08800293192275: T4510L
• 08800293192268: T4508L
• 08800293192251: T4507L
• 08800293192244: T4013L
• 08800293192237: T4011L
• 08800293192220: T4010L
• 08800293192213: T4008L
• 08800293192206: T4007L
• 08800293192190: T3613L
• 08800293192183: T3611L
• 08800293192176: T3610L
• 08800293192169: T3608L
• 08800293192152: T3607L
• 08800293192145: T5013R
• 08800293192121: T5010R
• 08800293192114: T5008R
• 08800293192107: T5007R
• 08800293192091: T4513R