IU SB Abutment Φ5.0

GUDID 08800026103561

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	08800026103561
NIH Device Record Key	0f46770d-65cd-4691-b437-c604a2fcf3c9
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU SB Abutment Φ5.0
Version Model Number	IUSB5065
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	08800026103561 [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

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

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 Φ5.0]

08800026108894	IUSB5064
08800026108887	IUSB5054
08800026108870	IUSB5044
08800026108863	IUSB5034
08800026108856	IUSB5024
08800026108849	IUSB5014
08800026103578	IUSB5067
08800026103561	IUSB5065
08800026103554	IUSB5057
08800026103547	IUSB5055
08800026103530	IUSB5047
08800026103523	IUSB5045
08800026103516	IUSB5037
08800026103509	IUSB5035
08800026103493	IUSB5027
08800026103486	IUSB5025
08800026103479	IUSB5017
08800026103462	IUSB5015

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