DIO Implant System IFI 4812PM

GUDID 18806195937492

The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to pr

DIO Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 18806195937492
• NIH Device Record Key: 0636bddb-5c35-46dd-8f9f-87ed00a1682a
• Commercial Distribution Discontinuation: 2015-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DIO Implant System
• Version Model Number: IFI 4812PM
• Catalog Number: IFI 4812PM
• 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	18806195937492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070570

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: 2015-09-21

On-Brand Devices [DIO Implant System]

• 18806195937904: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937898: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937881: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937874: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937867: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937850: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937843: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937836: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937829: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937812: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937805: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937799: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937782: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937775: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937768: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937751: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937744: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937737: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937720: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937713: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937706: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937690: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937683: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937676: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937669: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937652: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937645: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937638: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937621: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937614: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937607: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937591: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937584: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937577: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937560: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937553: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937508: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937492: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937485: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937478: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937461: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937454: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937447: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937430: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937423: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937416: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937409: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195937393: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195936693: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi
• 18806195936686: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for surgi