Ti Link Abutment

GUDID 08800070220429

Izenimplant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800070220429
• NIH Device Record Key: 9326944e-0d2f-48ed-899b-77e160b244c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti Link Abutment
• Version Model Number: TLATRN4510S
• Company DUNS: 694625347
• Company Name: Izenimplant 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: false
• 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	08800070220429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232170

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

[08800070220429]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-29
• Device Publish Date: 2024-01-19

On-Brand Devices [Ti Link Abutment]

• 08800070220436: TLATRN4520S
• 08800070220429: TLATRN4510S
• 08800070220412: TLATMN4020S
• 08800070220405: TLATMN4010S
• 08800070220399: TLATRH4520S
• 08800070220382: TLATRH4510S
• 08800070220375: TLATMH4020S
• 08800070220368: TLATMH4010S
• 08800070220351: TLASRN4520S
• 08800070220344: TLASRN4510S
• 08800070220337: TLASRH4520S
• 08800070220320: TLASRH4510S
• 08800070220269: TLATRN4520
• 08800070220252: TLATRN4510
• 08800070220245: TLATMN4020
• 08800070220238: TLATMN4010
• 08800070220221: TLATRH4520
• 08800070220214: TLATRH4510
• 08800070220207: TLATMH4020
• 08800070220191: TLATMH4010
• 08800070220184: TLASRN4520
• 08800070220177: TLASRN4510
• 08800070220160: TLASRH4520
• 08800070220153: TLASRH4510