BONE LEVEL TIBASE 4035-TiB

GUDID D7854035TIB0

4.0MM TITANIUM BASE W/LOCKING SCREW

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D7854035TIB0
• NIH Device Record Key: c88bd665-4907-4462-b552-4a71cbed9221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONE LEVEL TIBASE
• Version Model Number: 4.0MM TITANIUM BASE W/LOCKING SCREW
• Catalog Number: 4035-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	D7854035TIB0 [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

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-22
• Device Publish Date: 2024-02-14

Devices Manufactured by OCO BIOMEDICAL INC

• D7850330T0 - Osteotomy Former: 2024-12-11 3.3mm Osteotomy Former 3.3mm Diameter For placement of the 3.6mm Engage Implant (Lower)
• D7853610ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 10mm Length
• D7853610ENGPLS0 - Two Stage Bone Level Implant: 2024-12-11 3.6mm diameter X 10mm length Engage Plus Bone Level Implant
• D7853612ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6MM Diameter X 12mm Length
• D7853612ENGPLS0 - Two Stage Bone Level Implant: 2024-12-11 3.6mm diameter X 12mm length Bone Level Implant
• D7853614ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 14mm Length
• D7853614ENGPLS0 - Two Stage Bone Level Implant: 2024-12-11 3.6mm diameter X 14mm length Bone Level Implant
• D7853616ENGAGE0 - Two Stage Bone Level Dental Implant: 2024-12-11 Two Stage Bone Level Dental Implant: 3.6mm Diameter X 16mm Length