IU Cover Screw

GUDID 08800026106500

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	08800026106500
NIH Device Record Key	561bceda-7658-4ad3-b552-8f5e464b3efe
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU Cover Screw
Version Model Number	IUCSA
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	08800026106500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

FDA Product Code

DZE	Implant, Endosseous, Root-Form

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

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 Cover Screw]

08800026106500	IUCSA
08800026106494	IUCS