IU Fixture

GUDID 08800026100997

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026100997
NIH Device Record Key16ae062f-b4ce-488a-a6a7-b66f4d37f027
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU Fixture
Version Model NumberFIU50115
Company DUNS688857820
Company NameWARANTEC.Co.,Ltd
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026100997 [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 Date2023-04-20
Device Publish Date2023-04-12

On-Brand Devices [IU Fixture]

08800026101086FIU60100
08800026101079FIU60085
08800026101062FIU60070
08800026101055FIU55130
08800026101048FIU55115
08800026101031FIU55100
08800026101024FIU55085
08800026101017FIU55070
08800026101000FIU50130
08800026100997FIU50115
08800026100980FIU50100
08800026100973FIU50085
08800026100966FIU50070
08800026100959FIU45130
08800026100942FIU45115
08800026100935FIU45100
08800026100928FIU45085
08800026100911FIU45070
08800026100904FIU40130
08800026100898FIU40115
08800026100881FIU40100
08800026100874FIU40085
08800026100867FIU40070
08800026100850FIU36130
08800026100843FIU36115
08800026100836FIU36100
08800026100829FIU36085

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