DIO STEADY External Implant System ESF 4513R

GUDID 18806195920265

The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provi

DIO Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 18806195920265
• NIH Device Record Key: d2a30ff7-04ea-4799-915b-66a51584be04
• Commercial Distribution Discontinuation: 2015-09-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DIO STEADY External Implant System
• Version Model Number: ESF 4513R
• Catalog Number: ESF 4513R
• 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

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *tmperature limitation 1˚C ~ 30˚C, Humidity 80%
• Special Storage Condition, Specify: Between 0 and 0 *tmperature limitation 1˚C ~ 30˚C, Humidity 80%

Device Identifiers

Device Issuing Agency	Device ID
GS1	18806195920265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100100

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-14

On-Brand Devices [DIO STEADY External Implant System]

• 18806195920760: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920753: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920746: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920739: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920722: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920715: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920708: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920692: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920685: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920678: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920661: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920654: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920647: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920630: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920623: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920616: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920609: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920593: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920586: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920579: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920562: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920555: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920548: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920531: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920524: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920517: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920500: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920494: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920487: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920470: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920463: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920456: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920449: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920432: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920425: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920418: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920401: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920395: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920388: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920371: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920364: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920357: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920340: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920333: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920326: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920319: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920302: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920296: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920289: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical
• 18806195920272: The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical