UCLA ENGAGING TIBASE 4.0 UCLA E (TiB)

GUDID D78540UCLAETIB0

4.0MM TSI/ERI/TITANIUM BASE UCLA ABUTMENT (ENGAGING)

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed
Primary Device IDD78540UCLAETIB0
NIH Device Record Key8ebd7793-e495-4a25-8711-b9b3e177ab28
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCLA ENGAGING TIBASE
Version Model Number4.0MM TSI/ERI/TITANIUM BASE UCLA ABUTMENT ENGAGING
Catalog Number4.0 UCLA E (TiB)
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
HIBCCD78540UCLAETIB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

Moist Heat or Steam Sterilization


[D78540UCLAETIB0]

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

Devices Manufactured by OCO BIOMEDICAL INC

D7856006ENGPLS0 - Two Stage Bone Level Implant2024-10-07 6mm diameter X 6mm length Bone Level Implant
D785293325CBTI0 - SDI Crown and Bridge Abutments (Ti)2024-07-08 2.9/3/3.25MM CONVERT OB TO CB ABUTMENT (TITANIUM)
D785SDI2225CBTI0 - SDI Crown and Bridge Abutments (Ti)2024-07-08 2.2/2.5MM SDI C&B ABUTMENT
D785002CAPWOBN0 - HOUSING CAP WITH O-RING2024-07-04 002 CAP WITH O-RING INSERTED (002BN900)
D785325SB0 - SCAN BODY2024-07-04 TSI/ERI 3.25MM SCAN BODY
D78540SB0 - SCAN BODY2024-07-04 TSI/ERI 4.0MM SCAN BODY
D78550SB0 - SCAN BODY2024-07-04 TSI/ERI 5.0MM SCAN BODY
D78562000 - Complete Surgical Kit2024-07-04 Complete Surgical Kit Caddy

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