AccessGUDID - DEVICE: UF Implant System (18806195930080)

GUDID

Device Identifier (DI) Information

Brand Name: UF Implant System
Version or Model: UF 5011S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: UF 5011S
Company Name: DIO Corporation

Primary DI Number: 18806195930080
Issuing Agency: GS1
Commercial Distribution End Date: September 14, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 631085206 *Terms of Use

Device Description: The DIO UF HSA Internal Sub-Merged Implant System is comprised of Dental Implants, Superstructures, Instruments for prosthetics and Surgical Instruments. The DIO UF HSA Internal Sub-Merged Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The Dental Implants, fixtures are made of commercial pure titanium, grade 4(ASTM F67) which have a S.L.A (Sand-blasted Large grit Acid-etched) treated surface. These fixtures can be used one-stage surgery method or two-stage surgery method. And that are surgically inserted into the upper and/or lower jaw bone. The fixtures replace tooth root as providing a stable foundation for restorations. The fixtures have the diameter(3.8 ~ 7.0mm)and length.(7 ~ 16mm)

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
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122519	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: ® Ø5.0X11.5mm

Device Record Status

Public Device Record Key: 061ce5c1-017d-4b1f-83db-4e2ef02a3695
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 11, 2015