AccessGUDID - DEVICE: DIO STEADY External Implant System (18806195920630)

GUDID

Device Identifier (DI) Information

Brand Name: DIO STEADY External Implant System
Version or Model: ETF 4515R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ETF 4515R
Company Name: DIO Corporation

Primary DI Number: 18806195920630
Issuing Agency: GS1
Commercial Distribution End Date: September 21, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 631085206 *Terms of Use

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

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 [?]
K100100	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: ® Ø4.5X15mm

Device Record Status

Public Device Record Key: cac5b636-3ba4-49a8-b7cb-db8520256ff8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2015