ENGAGE TIBASE LONG 5045 TiBASE L

GUDID D7855045TIBASEL0

5.0 ENGAGE TIBASE LONG

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7855045TIBASEL0
• NIH Device Record Key: 2d57238c-c586-4bb2-ba3d-4f678347c114
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENGAGE TIBASE LONG
• Version Model Number: 5.0 ENGAGE TIBASE LONG
• Catalog Number: 5045 TiBASE L
• 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	D7855045TIBASEL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090174

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

[D7855045TIBASEL0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by OCO BIOMEDICAL INC

• D785AS3100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 3.25mm
• D785AS4100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 4.0/5.0mm
• D78529SDIOBPK0 - 2.9 SDI O-BALL PROSTHETIC KIT: 2024-04-29 2.9MM SDI O-BALL PROSTHETIC KIT
• D78540TPKOB0 - TSI PROSTHETIC KIT: 2024-04-25 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT
• D785325ICBPK0 - ISI C&B PROSTHETIC KIT: 2024-04-17 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
• D785002ORKIT0 - O-RING PACK: 2024-04-11 002 O-Ring Kit
• D785003ORKIT0 - O-RING PACK: 2024-04-11 003 O-Ring Kit
• D785002CAPWO0 - HOUSING CAP WITH O-RING: 2024-03-20 002 CAP WITH 002 BLK O-RING INSERTED