SM Implant System SFR 4510

GUDID 08806195921883

The DIO SM Implant System is comprised of dental implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully ossecintegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use, in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

DIO Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806195921883
• NIH Device Record Key: f013ab09-80ec-4018-a692-3c4900b4e886
• Commercial Distribution Discontinuation: 2022-02-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SM Implant System
• Version Model Number: SFR 4510
• Catalog Number: SFR 4510
• Company DUNS: 631085206
• Company Name: DIO Corporation
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806195921883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061797

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-02-25
• Device Publish Date: 2015-10-22

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