SPI ELEMENT

GUDID 07640156471328

Thommen Medical AG

Screw endosteal dental implant, two-piece
Primary Device ID07640156471328
NIH Device Record Key4bd95211-b242-4884-aeb9-e00dc4124832
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPI ELEMENT
Version Model Number4.13.952
Company DUNS481614829
Company NameThommen Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS107640156471328 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [SPI ELEMENT]

076401564787784.13.949
076401564787094.13.939
076401564786934.13.929
076401564786864.13.919
076401564786794.13.909
076401564715334.13.900
076401564715264.13.901
076401564715194.13.902
076401564715024.13.904
076401564714964.13.910
076401564714894.13.911
076401564714724.13.912
076401564714654.13.914
076401564714584.13.920
076401564714414.13.921
076401564714344.13.922
076401564714274.13.924
076401564714104.13.930
076401564714034.13.931
076401564713974.13.934
076401564713804.13.940
076401564713734.13.941
076401564713664.13.942
076401564713594.13.944
076401564713424.13.950
076401564713354.13.951
076401564713284.13.952
076401564708574.13.905
076401564708404.13.906
076401564708334.13.907
076401564708264.13.903
076401564708194.13.908
076401564708024.13.913
076401564707964.13.943
076401564707894.13.953

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.