Bone Level Healing Screw 4035-HS

GUDID D7854035HS0

4mm Healing Screw 4mm Diameter

OCO BIOMEDICAL INC

Dental implant system

• Primary Device ID: D7854035HS0
• NIH Device Record Key: 99a9cf04-fba7-45db-9a0f-0e9dc05a7ae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Level Healing Screw
• Version Model Number: 4mm Healing Screw
• Catalog Number: 4035-HS
• 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: false
• 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	D7854035HS0 [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

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

Moist Heat or Steam Sterilization

[D7854035HS0]

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 Healing Screw]

• D7856057HS0: 6mm Healing Screw 6mm Diameter
• D7855045HS0: 5mm Healing Screw 5mm Diameter
• D7854035HS0: 4mm Healing Screw 4mm Diameter
• D78532530HS0: 3.25mm Healing Screw 3.25mm Diameter