2.9 SDI O-BALL PROSTHETIC KIT 2.9 SDI-OB PK

GUDID D78529SDIOBPK0

2.9MM SDI O-BALL PROSTHETIC KIT

OCO BIOMEDICAL INC

Dental prosthesis/implant abutment screw analog, single-use

• Primary Device ID: D78529SDIOBPK0
• NIH Device Record Key: b8083a26-bf66-4783-9654-deb7c8f943fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.9 SDI O-BALL PROSTHETIC KIT
• Version Model Number: 2.9MM SDI O-BALL PROSTHETIC KIT
• Catalog Number: 2.9 SDI-OB PK
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	D78529SDIOBPK0 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-29
• Device Publish Date: 2024-04-19

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