Ball Abutment

GUDID 08800070219430

Izenimplant Co., Ltd.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

Primary Device ID	08800070219430
NIH Device Record Key	6a43ecba-2a1e-4e7a-8dba-f8f1e8cd35c8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ball Abutment
Version Model Number	BASR3520
Company DUNS	694625347
Company Name	Izenimplant Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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	false
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	08800070219430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211090

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous