UCLA ENGAGING DELRIN 4.0 UCLA E (DEL)

GUDID D78540UCLAEDEL0

4.0MM TSI/ERI DELRIN UCLA ABUTMENT (ENGAGING)

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: D78540UCLAEDEL0
• NIH Device Record Key: 994134b0-d10c-4ca5-860e-0767dec24747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCLA ENGAGING DELRIN
• Version Model Number: 4.0MM TSI/ERI DELRIN UCLA ABUTMENT ENGAGING
• Catalog Number: 4.0 UCLA E (DEL)
• 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	D78540UCLAEDEL0 [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

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

Moist Heat or Steam Sterilization

[D78540UCLAEDEL0]

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

• D785002CAPWOBN0 - HOUSING CAP WITH O-RING: 2024-07-04 002 CAP WITH O-RING INSERTED (002BN900)
• D785325SB0 - SCAN BODY: 2024-07-04 TSI/ERI 3.25MM SCAN BODY
• D78540SB0 - SCAN BODY: 2024-07-04 TSI/ERI 4.0MM SCAN BODY
• D78550SB0 - SCAN BODY: 2024-07-04 TSI/ERI 5.0MM SCAN BODY
• D78562000 - Complete Surgical Kit: 2024-07-04 Complete Surgical Kit Caddy
• D78562010 - Small Diameter Surgical Kit: 2024-07-04 Small Diameter Surgical Kit Caddy
• D78562020 - Osteotome Tray: 2024-07-04 Osteotome Tray
• D78562050 - Engage Compact Kit: 2024-07-04 Engage Compact Kit Case