AccessGUDID - DEVICE: DIO IMPLANT SYSTEMS (08806195926635)

GUDID

Device Identifier (DI) Information

Brand Name: DIO IMPLANT SYSTEMS
Version or Model: AAI 35015NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AAI 35015NA
Company Name: DIO Corporation

Primary DI Number: 08806195926635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631085206 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070570	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: tmperature limitation 1˚C ~ 30˚C, Humidity 80%

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Ø3.5(15˚)mm

Device Record Status

Public Device Record Key: e16f1aaa-587d-4aed-8550-48340876b77b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 19, 2016