TSI OFFSET ABUTMENT SPLINE 4250 TSI S (SPLINE)

GUDID D7854250TSISSP0

4.0mm OFFSET SHIELD ABUTMENT SHORT (SPLINE)

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed
Primary Device IDD7854250TSISSP0
NIH Device Record Keyd17e940c-c559-46b0-8f5c-74e75f4f3de3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSI OFFSET ABUTMENT SPLINE
Version Model Number4.0mm OFFSET SHIELD ABUTMENT SHORT SPLINE
Catalog Number4250 TSI S (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
HIBCCD7854250TSISSP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


[D7854250TSISSP0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-22
Device Publish Date2024-02-14

On-Brand Devices [TSI OFFSET ABUTMENT SPLINE]

D7854250TSISSP04.0mm OFFSET SHIELD ABUTMENT SHORT (SPLINE)
D7854250TSILSP04.0mm OFFSET SHIELD ABUTMENT LONG (SPLINE)
D7854200TSISP04.0 & 5.0mm TSI HEX INDEXING OFF-SET ABUTMENT (SPLINE)

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