ISI C&B PROSTHETIC KIT 3.25 I-CB PK

GUDID D785325ICBPK0

3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT

OCO BIOMEDICAL INC

Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use Dental prosthesis/implant abutment screw analog, single-use

• Primary Device ID: D785325ICBPK0
• NIH Device Record Key: 1281deb0-03ba-4178-817b-2a1822613870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISI C&B PROSTHETIC KIT
• Version Model Number: 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
• Catalog Number: 3.25 I-CB 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	D785325ICBPK0 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-17
• Device Publish Date: 2024-02-27

On-Brand Devices [ISI C&B PROSTHETIC KIT]

• D78540ICBPKF0: 4.0MM ISI CROWN AND BRIDGE PROSTHETIC KIT
• D785325ICBPKF0: 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
• D785325ICBPK0: 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT