Straight Shielded Abutment 5150 TSI L (SPLINE)

GUDID D7855150TSILSP0

TSI Straight Shielded Abutment 5mm Diameter Spline Long

OCO BIOMEDICAL INC

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Primary Device ID	D7855150TSILSP0
NIH Device Record Key	9035d80c-b51e-411e-ae88-54fad9305690
Commercial Distribution Status	In Commercial Distribution
Brand Name	Straight Shielded Abutment
Version Model Number	5mm Straight Shielded Abutment
Catalog Number	5150 TSI L (SPLINE)
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	D7855150TSILSP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090174

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous