DIO Implant System - The DIO Dental Implant system is an endosseous - DIO Corporation

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.

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More Product Details

Catalog Number

PSI 4810P

Brand Name

DIO Implant System

Version/Model Number

PSI 4810P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2015

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

64727179-d8f0-4752-a26c-31bda3ecbdba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIO CORPORATION" Characteristics
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