IU Ball Attachment Abutment

GUDID 08800026104391

WARANTEC.Co.,Ltd

Dental implant system
Primary Device ID08800026104391
NIH Device Record Key5c0f0239-24f0-4b35-804f-cf60cbaa4152
Commercial Distribution StatusIn Commercial Distribution
Brand NameIU Ball Attachment Abutment
Version Model NumberIUBA5040
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
GS108800026104391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

Moist Heat or Steam Sterilization


[08800026104391]

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 Ball Attachment Abutment]

08800026104414IUBA5060
08800026104407IUBA5050
08800026104391IUBA5040
08800026104384IUBA5030
08800026104377IUBA5020
08800026104360IUBA5010
08800026104353IUBA4060A
08800026104346IUBA4050A
08800026104339IUBA4040A
08800026104322IUBA4030A
08800026104315IUBA4020A
08800026104308IUBA4010A

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