SPI ELEMENT INICELL

GUDID 07640156471274

Thommen Medical AG

Screw endosteal dental implant, two-piece
Primary Device ID07640156471274
NIH Device Record Key4e3f0ae3-abb3-4e2a-9043-eac515d00c7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPI ELEMENT INICELL
Version Model Number4.23.116
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
GS107640156471274 [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 INICELL]

076401564785634.23.106
076401564785564.23.105
076401564785494.23.104
076401564785324.23.103
076401564785254.23.102
076401564729674.23.112
076401564713044.23.113
076401564712984.23.114
076401564712814.23.115
076401564712744.23.116
076401564712674.23.117
076401564712504.23.122
076401564712434.23.123
076401564712364.23.124
076401564712294.23.125
076401564712124.23.126
076401564712054.23.132
076401564711994.23.133
076401564711824.23.134
076401564711754.23.135
076401564711684.23.136
076401564711514.23.137
076401564711444.23.142
076401564711374.23.143
076401564711204.23.144
076401564711134.23.145
076401564711064.23.146
076401564708884.23.121
076401564708714.23.131
076401564708644.23.141
076401564707724.23.152
076401564707654.23.151
076401564707584.23.153
076401564707414.23.154
076401564707344.23.155
076401564703454.23.512
076401564703384.23.712
076401564703214.23.513
076401564703144.23.713
076401564703074.23.514
076401564702914.23.714
076401564702844.23.515
076401564702774.23.715
076401564702604.23.516
076401564702534.23.716
076401564702464.23.721
076401564702394.23.522
076401564702224.23.722
076401564702154.23.523
076401564702084.23.723

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