Duns Number:631085206
Device Description: The DIO Dental Implant system is an endosseous dental implant that is indicated to use for The DIO Dental Implant system is an endosseous dental implant that is indicated to use 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. The DIO implant system is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.
Catalog Number
PSI 4008
Brand Name
DIO Implant System
Version/Model Number
PSI 4008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2015
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070570
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
39dace26-8237-4b66-8a4d-a23d0d0ef00f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3540 |