IU Healing Abutment

GUDID 08800026102434

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	08800026102434
NIH Device Record Key	edf0ac57-2d72-4b2f-9bd0-37f182b54ca7
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU Healing Abutment
Version Model Number	IUHA5010
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	08800026102434 [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 Healing Abutment]

08800026106036	IUHA6060
08800026102533	IUHA6050
08800026102526	IUHA6040
08800026102519	IUHA6030
08800026102502	IUHA6020
08800026102496	IUHA6010
08800026102489	IUHA5060
08800026102472	IUHA5050
08800026102465	IUHA5040
08800026102458	IUHA5030
08800026102441	IUHA5020
08800026102434	IUHA5010
08800026102427	IUHA4060
08800026102410	IUHA4050
08800026102403	IUHA4040
08800026102397	IUHA4030
08800026102380	IUHA4020
08800026102373	IUHA4010
08800026102366	IUHA5060A
08800026102359	IUHA5050A
08800026102342	IUHA5040A
08800026102335	IUHA5030A
08800026102328	IUHA5020A
08800026102311	IUHA5010A
08800026102304	IUHA4060A
08800026102298	IUHA4050A
08800026102281	IUHA4040A
08800026102274	IUHA4030A
08800026102267	IUHA4010A
08800026102243	IUHA4020A