Bone Level Abutment 4035-1MUA

GUDID D78540351MUA0

4mm Multi Unit Abutment 4mm Diameter 1mm Height 3.5mm Platform

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D78540351MUA0
• NIH Device Record Key: ac8c2f1b-73cb-4710-8fa6-7cd9146fd435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Abutment
• Version Model Number: 4mm Multi Unit Abutment
• Catalog Number: 4035-1MUA
• 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	D78540351MUA0 [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

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

Moist Heat or Steam Sterilization

[D78540351MUA0]

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: 2016-04-20

On-Brand Devices [Bone Level Abutment]

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• D78550455MUA300: 5mm Multi Unit Abutment 30 Degree 5mm Diameter 5mm Height 4.5mm Platform
• D78550455MUA0: 5mm Multi Unit Abutment 17 Degree 5mm Diameter 5mm Height 4.5mm Height
• D78550454MUA300: 5mm Multi Unit Abutment 30 Degree 5mm Diameter 3mm Height 4.5mm Platform
• D78550453MUA30: 5mm Multi Unit Abutment 5mm Diameter 3mm Height 4.5mm Platform
• D78550453MUA0: 5mm Multi Unit Abutment 17 Degree 5mm Diameter 3mm Height 4.5mm Platform
• D78550452MUA20: 5mm Multi Unit Abutment 5mm Diameter 2mm Height 4.5mm Platform
• D78550452MUA0: 5mm Multi Unit Abutment 17 Degree 5mm Diameter 2mm Height 4.5mm Platform
• D78550451MUA0: 5mm Multi Unit Abutment 5mm Diameter 1mm Height 4.5mm Platform
• D78540353MUA170: 4mm Multi Unit Abutment 17 Degree 4mm Diameter 3mm Height 3.5mm Platform
• D78540353MUA0: 4mm Multi Unit Abutment 30 Degree Angle 4mm Diameter 3mm Height 3.5mm Platform
• D78540352MUA170: 4mm Multi Unit Abutment 17 Degree 4mm Diameter 2mm Height 3.5mm Platform
• D78540352MUA0: 4mm Multi Unit Abutment 4mm Diameter 2mm Height 3.5mm Platform
• D78540351MUA0: 4mm Multi Unit Abutment 4mm Diameter 1mm Height 3.5mm Platform