IU Attachment Retained Abutment

GUDID 08800026104438

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026104438
NIH Device Record Key75805e11-d200-4341-9a99-e598538b0870
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU Attachment Retained Abutment
Version Model NumberIULA4320A
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
GS108800026104438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

Moist Heat or Steam Sterilization


[08800026104438]

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 Attachment Retained Abutment]

08800026104537IULA4360
08800026104520IULA4350
08800026104513IULA4340
08800026104506IULA4330
08800026104490IULA4320
08800026104483IULA4310
08800026104476IULA4360A
08800026104469IULA4350A
08800026104452IULA4340A
08800026104445IULA4330A
08800026104438IULA4320A
08800026104421IULA4310A

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