IU SB Abutment_Non hex Φ5.0

GUDID 08800026103967

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	08800026103967
NIH Device Record Key	35f674e0-031e-4176-b446-fbbcef674028
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU SB Abutment_Non hex Φ5.0
Version Model Number	IUSB5025N
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	08800026103967 [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

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

Moist Heat or Steam Sterilization

[08800026103967]

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_Non hex Φ5.0]

08800026109464	IUSB5064N
08800026109457	IUSB5054N
08800026109440	IUSB5044N
08800026109433	IUSB5034N
08800026109426	IUSB5024N
08800026109419	IUSB5014N
08800026104056	IUSB5067N
08800026104049	IUSB5065N
08800026104032	IUSB5057N
08800026104025	IUSB5055N
08800026104018	IUSB5047N
08800026104001	IUSB5045N
08800026103998	IUSB5037N
08800026103981	IUSB5035N
08800026103974	IUSB5027N
08800026103967	IUSB5025N
08800026103950	IUSB5017N
08800026103943	IUSB5015N

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.