BONE LEVEL TIBASE 4035-TiB

GUDID D7854035TIB0

4.0MM TITANIUM BASE W/LOCKING SCREW

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed
Primary Device IDD7854035TIB0
NIH Device Record Keyc88bd665-4907-4462-b552-4a71cbed9221
Commercial Distribution StatusIn Commercial Distribution
Brand NameBONE LEVEL TIBASE
Version Model Number4.0MM TITANIUM BASE W/LOCKING SCREW
Catalog Number4035-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
HIBCCD7854035TIB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

Moist Heat or Steam Sterilization


[D7854035TIB0]

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

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
D78562010 - Small Diameter Surgical Kit2024-07-04 Small Diameter Surgical Kit Caddy

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