Cemented Octa Abutment

GUDID 08806169105387

Ø6.0, L:8.0mm

DENTIS CO., LTD.

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Primary Device ID	08806169105387
NIH Device Record Key	83e008bb-bdc8-4db3-a2de-9f9b6e4c936c
Commercial Distribution Discontinuation	2019-05-03
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Cemented Octa Abutment
Version Model Number	DECRW10
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	08806169105387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K082843

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous