Cemented Abutment Mini

GUDID 08800055761510

ARUM DENTISTRY Co., Ltd.

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Primary Device ID	08800055761510
NIH Device Record Key	22d98410-f6a7-478f-be02-be47888e09c8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cemented Abutment Mini
Version Model Number	SACH4545M
Company DUNS	557821945
Company Name	ARUM DENTISTRY 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	08800055761510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K240091

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous