IU SB Abutment_hex Φ6.0

GUDID 08800026103189

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	08800026103189
NIH Device Record Key	43f66331-04b2-48a8-a36f-0b4f8dc7a8e0
Commercial Distribution Status	In Commercial Distribution
Brand Name	IU SB Abutment_hex Φ6.0
Version Model Number	IUSB6055H
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	08800026103189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172345

FDA Product Code

DZE	Implant, Endosseous, Root-Form