DIO STEADY External Implant System

Basic Information

• Brand Name: DIO STEADY External Implant System
• Primary DI: 18806195920173
• Version / Model: ESF 4008R
• Catalog Number: ESF 4008R
• Company Name: DIO Corporation
• Labeler DUNS: 631085206
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: eaf39445-1d8e-47f1-b0c3-cf56a5db42d8
• Distribution End Date: 2015-09-14

Device Description

The DIO STEADY External Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units` prosthetic appliance attachment to restore a patient`s chewing function. Implants can be placed with a conventional two stage surgical process with an option for immediate loading. Immediate loading is restricted to the anterior mandible, based on four interforminal placed implants, and not indicated for single unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZE	Implant, Endosseous, Root-Form	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55849	Screw endosteal dental implant, two-piece	A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18806195920173	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100100	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			® Ø4.0X8.5mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: tmperature limitation 1˚C ~ 30˚C, Humidity 80%