One Stage TL

GUDID 00810027860033

I3 IMPLANT LLC

Dental implant suprastructure, temporary, custom-made
Primary Device ID00810027860033
NIH Device Record Keybd445b14-47c7-4dce-a586-ebb9e182d485
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne Stage TL
Version Model NumberI3022040
Company DUNS026108395
Company NameI3 IMPLANT LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810027860033 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810027860033]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-01
Device Publish Date2019-06-14

On-Brand Devices [One Stage TL]

00810027860019I3022020
00810027860002I3022010
00810027860200I3032120
00810027860194I3032110
00810027860187I3032100
00810027860170I3032090
00810027860163I3032070
00810027860156I3032050
00810027860149I3032030
00810027860132I3032020
00810027860125I3032010
00810027860118I3023050
00810027860101I3023040
00810027860095I3023030
00810027860088I3023020
00810027860071I3023010
00810027860064I3022070
00810027860057I3022060
00810027860040I3022050
00810027860033I3022040
00810027860026I3022030

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