IU SB Abutment Φ4.0

GUDID 08800026108771

WARANTEC.Co.,Ltd

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

Primary Device ID	08800026108771
NIH Device Record Key	049b060a-d394-428f-97cf-6b2694f4bb21
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU SB Abutment Φ4.0
Version Model Number	IUSB4034A
Company DUNS	688857820
Company Name	WARANTEC.Co.,Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026108771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172345

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

[08800026108771]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-20
Device Publish Date	2023-04-12

On-Brand Devices [IU SB Abutment Φ4.0]

08800026108832	IUSB4064A
08800026108825	IUSB4064
08800026108818	IUSB4054A
08800026108801	IUSB4054
08800026108795	IUSB4044A
08800026108788	IUSB4044
08800026108771	IUSB4034A
08800026108764	IUSB4034
08800026108757	IUSB4024A
08800026108740	IUSB4024
08800026108733	IUSB4014A
08800026108726	IUSB4014
08800026103813	IUSB4067A
08800026103806	IUSB4065A
08800026103790	IUSB4057A
08800026103783	IUSB4055A
08800026103776	IUSB4047A
08800026103769	IUSB4045A
08800026103752	IUSB4037A
08800026103745	IUSB4035A
08800026103738	IUSB4027A
08800026103721	IUSB4025A
08800026103714	IUSB4017A
08800026103707	IUSB4015A
08800026103448	IUSB4065
08800026103431	IUSB4057
08800026103424	IUSB4055
08800026103417	IUSB4047
08800026103400	IUSB4045
08800026103394	IUSB4037
08800026103387	IUSB4035
08800026103370	IUSB4027
08800026103363	IUSB4025
08800026103356	IUSB4017
08800026103349	IUSB4015

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