UT Fixture

GUDID 08800026101239

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026101239
NIH Device Record Key41c625dc-b10b-4aab-858a-898b6a2bdb7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameUT Fixture
Version Model NumberFUT53130
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
GS108800026101239 [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 [UT Fixture]

08800026101277FUT63115
08800026101260FUT63100
08800026101253FUT63085
08800026101246FUT63070
08800026101239FUT53130
08800026101222FUT53115
08800026101215FUT53100
08800026101208FUT53085
08800026101192FUT53070
08800026101185FUT48130
08800026101178FUT48115
08800026101161FUT48100
08800026101154FUT48085
08800026101147FUT48070
08800026101130FUT43130
08800026101123FUT43115
08800026101116FUT43100
08800026101109FUT43085
08800026101093FUT43070

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