Scan Healing Abutment Screw

GUDID 08800055793290

ARUM DENTISTRY Co., Ltd.

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Primary Device ID	08800055793290
NIH Device Record Key	e64c7916-68a8-468a-bda7-dde8ec50cbef
Commercial Distribution Status	In Commercial Distribution
Brand Name	Scan Healing Abutment Screw
Version Model Number	HAS-S12R
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	08800055793290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230725

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous