IU Top Abutment_hex Φ3.8

GUDID 08800026123378

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026123378
NIH Device Record Key6cb1435c-ee9b-4e07-a36f-6c77330b687a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU Top Abutment_hex Φ3.8
Version Model NumberI0UTA3864HA
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
GS108800026123378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


[08800026123378]

Moist Heat or Steam Sterilization


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 Top Abutment_hex Φ3.8]

08800026123422I0UTA3856HA
08800026123415I0UTA3846HA
08800026123408I0UTA3836HA
08800026123392I0UTA3826HA
08800026123385I0UTA3816HA
08800026123378I0UTA3864HA
08800026123361I0UTA3854HA
08800026123354I0UTA3844HA
08800026123347I0UTA3824HA
08800026123330I0UTA3814HA
08800026115809I0UTA3834HA
08800026112983I0UTA3866HA

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