IU SB Abutment_hex Φ4.0

GUDID 08800026102946

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	08800026102946
NIH Device Record Key	5a8197c6-cc1c-46e4-9744-2d39f2b9383f
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU SB Abutment_hex Φ4.0
Version Model Number	IUSB4055H
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	08800026102946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172345

FDA Product Code

DZE	Implant, Endosseous, Root-Form

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

Moist Heat or Steam Sterilization

[08800026102946]

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_hex Φ4.0]

08800026109228	IUSB4064HA
08800026109211	IUSB4064H
08800026109204	IUSB4054HA
08800026109198	IUSB4054H
08800026109181	IUSB4044HA
08800026109174	IUSB4044H
08800026109167	IUSB4034HA
08800026109150	IUSB4034H
08800026109143	IUSB4024HA
08800026109136	IUSB4024H
08800026109129	IUSB4014HA
08800026109112	IUSB4014H
08800026103332	IUSB4067HA
08800026103325	IUSB4065HA
08800026103318	IUSB4057HA
08800026103301	IUSB4055HA
08800026103295	IUSB4047HA
08800026103288	IUSB4045HA
08800026103271	IUSB4037HA
08800026103264	IUSB4035HA
08800026103257	IUSB4027HA
08800026103240	IUSB4025HA
08800026103233	IUSB4017HA
08800026103226	IUSB4015HA
08800026102977	IUSB4067H
08800026102960	IUSB4065H
08800026102953	IUSB4057H
08800026102946	IUSB4055H
08800026102939	IUSB4047H
08800026102922	IUSB4045H
08800026102915	IUSB4037H
08800026102908	IUSB4035H
08800026102892	IUSB4027H
08800026102885	IUSB4025H
08800026102878	IUSB4017H
08800026102861	IUSB4015H

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