i-Clean Gold Cylinder

GUDID 08806169109033

Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)

DENTIS CO., LTD.

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Primary Device ID	08806169109033
NIH Device Record Key	11398b51-0b1e-420f-a3e4-78bd45a41888
Commercial Distribution Status	In Commercial Distribution
Brand Name	i-Clean Gold Cylinder
Version Model Number	DIOGCWOS
Company DUNS	688204158
Company Name	DENTIS 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	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	08806169109033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171027

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous