DIO IMPLANT SYSTEMS

Basic Information

• Brand Name: DIO IMPLANT SYSTEMS
• Primary DI: 08806195926697
• Version / Model: AAI 35025NB
• Catalog Number: AAI 35025NB
• Company Name: DIO Corporation
• Labeler DUNS: 631085206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4caf58f2-bfa0-461c-ba88-165ac1ec3dd0

Device Description

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.

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
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	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	08806195926697	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070570	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Ø3.5(25˚)mm

Storage Conditions

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