TSI TIBASE 5.0 TIB

GUDID D78550TIB0

5.0MM TITANIUM BASE SCANNABLE ABUTMENT W/LOCKING SCREW

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D78550TIB0
• NIH Device Record Key: a33db980-6d18-4664-a3d6-1c761efc5884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI TIBASE
• Version Model Number: 5.0MM TITANIUM BASE SCANNABLE ABUTMENT W/LOCKING S
• Catalog Number: 5.0 TIB
• 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	D78550TIB0 [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

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

[D78550TIB0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-19
• Device Publish Date: 2024-02-15

On-Brand Devices [TSI TIBASE]

• D78550TIB0: 5.0MM TITANIUM BASE SCANNABLE ABUTMENT W/LOCKING SCREW
• D785325TIB0: 3.25MM TITANIUM BASE SCANNABLE ABUTMENT W/LOCKING SCREW