TIBASE LONG 4035 TiBASE L

GUDID D7854035TIBASEL0

4.0 ENGAGE TIBASE LONG

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7854035TIBASEL0
• NIH Device Record Key: 14453910-bb9a-4c32-bd43-f1803584d037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIBASE LONG
• Version Model Number: 4.0 ENGAGE TIBASE LONG
• Catalog Number: 4035 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	D7854035TIBASEL0 [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

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

Moist Heat or Steam Sterilization

[D7854035TIBASEL0]

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

On-Brand Devices [TIBASE LONG]

• D7854035TIBASEL0: 4.0 ENGAGE TIBASE LONG
• D78532530TIBASEL0: 3.25 ENGAGE TIBASE LONG