DIO IMPLANT SYSTEMS ABN 40505

GUDID 08800049233443

The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These implants are surgically inserted into the upper and/or lower jawbone, and serve as a substitute or replacement tooth root providing a stable foundation for 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 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: 08800049233443
• NIH Device Record Key: cedf97b0-27e9-40bf-af8a-62ce4b032b4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIO IMPLANT SYSTEMS
• Version Model Number: ABN 40505
• Catalog Number: ABN 40505
• 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: false
• 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

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 Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049233443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070570

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

[08800049233443]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [DIO IMPLANT SYSTEMS]

• 08806195928905: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195928899: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195928950: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195928943: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195928912: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195927076: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195927069: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195927052: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195927045: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195926512: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195926505: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195926499: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195926482: The DIO Implant System includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937907: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937891: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937884: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937877: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937860: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937853: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937846: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937839: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937822: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937815: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937808: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937792: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937785: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937778: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937761: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937754: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937747: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937730: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937723: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937716: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937709: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937693: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937686: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937679: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937662: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937655: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937648: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937631: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937624: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937617: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937600: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937594: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937587: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937570: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937563: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937556: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These
• 08806195937549: The DIO Implant system includes one-stage fixture and two-stage fixture made of titanium. These