TSI/ERI Abutment Screw AS 3100 TSI

GUDID D785AS3100TSI0

TSI/ERI Abutment Screw 3.25mm

OCO BIOMEDICAL INC

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Primary Device ID	D785AS3100TSI0
NIH Device Record Key	97005abb-62c3-4df1-8b30-923cf69d9ef8
Commercial Distribution Status	In Commercial Distribution
Brand Name	TSI/ERI Abutment Screw
Version Model Number	Abutment Screw for 3.25mm TSI/ERI
Catalog Number	AS 3100 TSI
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	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
HIBCC	D785AS3100TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090174

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous