Straight Shielded Abutment 5150 TSI L (SPLINE)

GUDID D7855150TSILSP0

TSI Straight Shielded Abutment 5mm Diameter Spline Long

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed
Primary Device IDD7855150TSILSP0
NIH Device Record Key9035d80c-b51e-411e-ae88-54fad9305690
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraight Shielded Abutment
Version Model Number5mm Straight Shielded Abutment
Catalog Number5150 TSI L (SPLINE)
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7855150TSILSP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


[D7855150TSILSP0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

On-Brand Devices [Straight Shielded Abutment]

D7856150TSIS0TSI Straight Shielded Abutment 6mm Diameter Short
D7856150TSIL0TSI Straight Shielded Abutment 6mm Diameter Long
D7855150TSIS0TSI Straight Shielded Abutment 5mm diameter Short
D7855150TSIL0TSI Straight Shielded Abutment 5mm Diameter Long
D7854150TSIS0TSI Straight Shielded Abutment 4mm Diameter Short
D7854150TSIL0TSI Straight Shielded Abutment 4mm Diameter Long
D7853150TSI0TSI Straight Shielded Abutment 3.25mm Diameter
D7855150TSILSP0TSI Straight Shielded Abutment 5mm Diameter Spline Long

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