TSI/ERI/Macro Healing Abutment 4065 TSI HC

GUDID D7854065TSIHC0

4mm TSI/ERI Healing Abutment (3mm Height) 4mm Diameter

OCO BIOMEDICAL INC

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Primary Device ID	D7854065TSIHC0
NIH Device Record Key	8170aa49-6f40-4b01-b509-b4ae091754a3
Commercial Distribution Status	In Commercial Distribution
Brand Name	TSI/ERI/Macro Healing Abutment
Version Model Number	TSI/ERI Healing Abutment (3mm Height)
Catalog Number	4065 TSI HC
Company DUNS	094146123
Company Name	OCO BIOMEDICAL INC
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	true
Manufacturing Date	false
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
HIBCC	D7854065TSIHC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090174

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous