Bone Level UCLA 5045 UCLA E (TiB)

GUDID D78550UCLAE0

5mm UCLA 5mm Diameter Engaging Delrin Ti Base

OCO BIOMEDICAL INC

Dental implant system Dental implant system 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: D78550UCLAE0
• NIH Device Record Key: a943e56d-464b-4668-b550-297455bad7f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level UCLA
• Version Model Number: 5mm UCLA
• Catalog Number: 5045 UCLA E (TiB)
• 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: true
• Manufacturing Date: false
• 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	D78550UCLAE0 [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

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

[D78550UCLAE0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-13

On-Brand Devices [Bone Level UCLA ]

• D78560UCLANE0: 6mm UCLA 6mm Diameter Non-Engaging Delrin Ti Base
• D78560UCLAE0: 6mm UCLA 6mm Diameter Engaging Delrin Ti Base
• D7856057UCLANEDEL0: 6mm UCLA NE (DEL) 6mm Diameter Non-Engaging Delrin Base
• D7856057UCLANE0: 7mm UCLA 7mm Diameter Non-Engaging Delrin Ti Base
• D7856057UCLAEDEL0: 6mm UCLA E (DEL) 6mm Diameter Engaging Delrin Base
• D7856057UCLAE0: 7mm UCLA 7mm Diameter Engaging Delrin Ti Base
• D78560578UCLANEDEL0: 8mm UCLA NE (DEL) 8mm Diameter Non-Engaging Delrin Base
• D78560578UCLANE0: 8mm UCLA 8mm Diameter Non-Engaging Delrin Ti Base
• D78560578UCLAEDEL0: 8mm UCLA E (DEL) 8mm Diameter Engaging Delrin Base
• D78560578UCLAE0: 8mm UCLA 8mm Diameter Engaging Delrin Ti Base
• D78560577UCLANEDEL0: 7mm UCLA NE (DEL) 7mm Diameter Non-Engaging Delrin Base
• D78560577UCLAEDEL0: 7mm UCLA E (DEL) 7mm Diameter Engaging Delrin Base
• D78550UCLANE0: 5mm UCLA 5mm Diameter Non-Engaging Delrin Ti Base
• D78550UCLAE0: 5mm UCLA 5mm Diameter Engaging Delrin Ti Base
• D7855045UCLANEDEL0: 5mm UCLA NE (DEL) 5mm Diameter Non-Engaging Delrin Base
• D7855045UCLAEDEL0: 5mm UCLA E (DEL) 5mm Diameter Engaging Delrin Base
• D78540UCLANE0: 4mm UCLA 4mm Diameter Non-Engaging Delrin Ti Base
• D78540UCLAE0: 4mm UCLA 4mm Diameter Engaging Delrin Ti Base
• D7854035UCLANEDEL0: 4mm UCLA NE (DEL) 4mm Diameter Non-Engaging Delrin Base
• D7854035UCLAEDEL0: 4mm UCLA E (DEL) 4mm Diameter Engaging Delrin Base
• D785325UCLANE0: 3.25mm UCLA 3.25mm Diameter Non-Engaging Delrin Ti Base
• D785325UCLAE0: 3.25 UCLA 3.25mm Diameter Engaging Delrin Ti Base
• D78532530UCLANEDEL0: 3.25mm UCLA NE (DEL) 3.25mm Diameter Non-Engaging Delrin Base