SCAN BODY 4035 SB

GUDID D7854035SB0

4.0MM ENGAGE SCAN BODY

OCO BIOMEDICAL INC

Dental implant abutment analog, scanning

• Primary Device ID: D7854035SB0
• NIH Device Record Key: 5b49042d-c5e4-4412-9b3e-b1e60d93e98c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCAN BODY
• Version Model Number: 4.0MM ENGAGE SCAN BODY
• Catalog Number: 4035 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	D7854035SB0 [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: 2024-03-20
• Device Publish Date: 2024-03-12

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