SCAN BODY 5.0 SB

GUDID D78550SB0

TSI/ERI 5.0MM SCAN BODY

OCO BIOMEDICAL INC

Dental implant abutment analog, scanning Dental implant abutment analog, scanning Dental implant abutment analog, scanning Dental implant abutment analog, scanning Dental implant abutment analog, scanning Dental implant abutment analog, scanning Dental implant abutment analog, scanning

• Primary Device ID: D78550SB0
• NIH Device Record Key: 47af29b4-f213-4eb4-9495-c5ae30d57ff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCAN BODY
• Version Model Number: TSI/ERI 5.0MM SCAN BODY
• Catalog Number: 5.0 SB
• 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: 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	D78550SB0 [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: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [SCAN BODY]

• D7856057SB0: 6.0MM ENGAGE SCAN BODY
• D7855045SB0: 5.0MM ENGAGE SCAN BODY
• D7854035SB0: 4.0MM ENGAGE SCAN BODY
• D78532530SB0: 3.25MM ENGAGE SCAN BODY
• D78550SB0: TSI/ERI 5.0MM SCAN BODY
• D78540SB0: TSI/ERI 4.0MM SCAN BODY
• D785325SB0: TSI/ERI 3.25MM SCAN BODY