SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm

GUDID 07640182643416

Thommen Medical AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07640182643416
• NIH Device Record Key: 8c80915b-8980-476e-b55f-80186878915f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm
• Version Model Number: 4.23.022
• Company DUNS: 481614829
• Company Name: Thommen Medical AG
• 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	07640182643416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090154

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: 2024-02-22
• Device Publish Date: 2024-02-14

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
• 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