Temporary Abutment

GUDID 08800070219003

Izenimplant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800070219003
• NIH Device Record Key: 371624ec-0622-448b-a2a1-7b01e256c604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temporary Abutment
• Version Model Number: TASXH4010
• 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	08800070219003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230630

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

[08800070219003]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-11
• Device Publish Date: 2023-08-03

On-Brand Devices [Temporary Abutment]

• 08800070219362: TATRN4530S
• 08800070219355: TATRN4510S
• 08800070219348: TATMN4030S
• 08800070219331: TATMN4010S
• 08800070219324: TATRH4530S
• 08800070219317: TATRH4510S
• 08800070219300: TATMH4030S
• 08800070219294: TATMH4010S
• 08800070219287: TASRN4530S
• 08800070219270: TASRN4510S
• 08800070219249: TASRH4530S
• 08800070219232: TASRH4510S
• 08800070219157: TATRN4530
• 08800070219140: TATRN4510
• 08800070219133: TATMN4030
• 08800070219126: TATMN4010
• 08800070219119: TATRH4530
• 08800070219102: TATRH4510
• 08800070219096: TATMH4030
• 08800070219089: TATMH4010
• 08800070219072: TASRN4530
• 08800070219065: TASRN4510
• 08800070219034: TASRH4530
• 08800070219027: TASRH4510
• 08800070219263: TASXN4030S
• 08800070219256: TASXN4010S
• 08800070219225: TASXH4030S
• 08800070219218: TASXH4010S
• 08800070219058: TASXN4030
• 08800070219041: TASXN4010
• 08800070219010: TASXH4030
• 08800070219003: TASXH4010