SPI®NEVO LC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 6.5 mm

GUDID 07640182643607

Thommen Medical AG

Screw endosteal dental implant, two-piece
Primary Device ID07640182643607
NIH Device Record Keyd59c992e-24f4-411c-9bb0-ff5cc29e1c93
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPI®NEVO LC INICELL®, healing cap incl., PF 4.5, endosseous Ø 4.2 mm, L 6.5 mm
Version Model Number4.23.781
Company DUNS481614829
Company NameThommen Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640182643607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-22
Device Publish Date2024-02-14

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 mm2024-02-22
07640182643362 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 9.5 mm2024-02-22
07640182643379 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 11.0 mm2024-02-22
07640182643386 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 12.5 mm2024-02-22
07640182643393 - SPI®NEVO RC INICELL®, healing cap incl., PF 3.5, endosseous Ø 3.5 mm, L 14.0 mm2024-02-22
07640182643409 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 6.5 mm2024-02-22
07640182643416 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 8.0 mm2024-02-22
07640182643423 - SPI®NEVO RC INICELL®, healing cap incl., PF 4.0, endosseous Ø 4.0 mm, L 9.5 mm2024-02-22

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