Gingiva former (4-lobe), narrow, PF 4.0, H 4.5 mm

GUDID 07640182642204

Thommen Medical AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07640182642204
• NIH Device Record Key: fa8ba0bb-7c19-4a2a-bcfa-4f6a2a36fad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gingiva former (4-lobe), narrow, PF 4.0, H 4.5 mm
• Version Model Number: 4.04.331
• Company DUNS: 481614829
• Company Name: Thommen Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640182642204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031747

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

[07640182642204]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-01
• Device Publish Date: 2023-05-24

Devices Manufactured by Thommen Medical AG

• 07640182643355 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 8.0 mm: 2024-02-22
• 07640182643362 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 9.5 mm: 2024-02-22
• 07640182643379 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 11.0 mm: 2024-02-22
• 07640182643386 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 12.5 mm: 2024-02-22
• 07640182643393 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 14.0 mm: 2024-02-22
• 07640182643409 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 6.5 mm: 2024-02-22
• 07640182643416 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm: 2024-02-22
• 07640182643423 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 9.5 mm: 2024-02-22