Duns Number:631085206
Device Description: DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and S DIO Protein Implant System consists of Protein Implants, Superstructure, Prosthetics and Surgical Instruments.The Protein Implants is an integrated system of endosseous dental implants which designed to protect main implant from immediate loading during osteointegration period, to increase indurance of temporary tooth and to conduct the immediate functions and immediate recovery of aesthetics of osteoimplanted area. These are made of titanium alloy which have a sandblasted, RBM(Resorbable Blast Media) treated surface. These implants are consist of one-stage, root-form dental implants which provide the clinician to maintain the patients' gingival contour. The Implants have the diameter(2.0/2.5mm) and length.(8/10/12/14mm).The superstructures consist of Protein Cemented Abutment, Ball Cap and Healing Cap. The Protein Cemented Abutments are made of titanium and intended for cement-retained restorations where conventional crown & bridge techniques are required. It can be used for single or multiple unit restorations. Ball Cap intended to retain the O-ring inside of the denture. Healing Cap is fixed on the ball type fixture to protect the direct pressure reduce the motion offixture.The Prosthetics and Surgical Instruments provide the clinician to choose only those components required for each clinical situation.The implants are gamma sterilized and intended to single use. And the surgical tools are nongamma sterilized and have to be sterilized by user before using.
Catalog Number
MFB 20210
Brand Name
DIO PROTEM IMPLANT SYSTEM
Version/Model Number
MFB 20210
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K080126
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
2d425e86-13a0-4c59-848e-9a28fd06b6b1
Public Version Date
March 09, 2022
Public Version Number
1
DI Record Publish Date
March 01, 2022
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 |