DIO UF HSA Internal Sub-Merged Implant System UF(II) 4015S

GUDID 08806195934333

The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the 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 Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 08806195934333
• NIH Device Record Key: 23d464b2-6247-402e-a4f4-a63a3b564d00
• Commercial Distribution Discontinuation: 2022-02-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIO UF HSA Internal Sub-Merged Implant System
• Version Model Number: UF(II) 4015S
• Catalog Number: UF(II) 4015S
• 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
• 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
• Phone: 213-365-2875
• Email: usahq@dioimplantusa.com

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Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806195934333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122519

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: 2022-02-16
• Device Publish Date: 2015-10-22

On-Brand Devices [DIO UF HSA Internal Sub-Merged Implant System]

• 08806195967829: ICC 65309N
• 08806195967812: ICC 60649N
• 08806195967805: ICC 48588N
• 08806195967799: ICC 48508N
• 08806195958926: STI 2004
• 08806195930090: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930083: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930076: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930069: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930052: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930038: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930021: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930014: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930007: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929995: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929988: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929964: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929957: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929940: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929933: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929919: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929902: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929896: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195929889: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08800049400067: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
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• 08806195934364: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934357: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934340: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934333: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934326: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934241: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934234: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934227: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934210: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934203: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934197: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934180: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934173: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195934166: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
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• 08806195934142: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
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• 08806195930342: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930335: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930328: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur
• 08806195930311: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructur