Duns Number:631085206
Device Description: The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and The DIO Biotite-H Implant System is comprised of dental implant, surgical instruments and prosthetic components. The DIO Biotite-H Implant System`s screw-form dental implant consist of machined titanium. Screw`s Diameter : Ø3.8mm, Ø4.1mm, Ø4.5mm, Ø4.8mm, Ø5.3mm. Length : 8.0mm, 10.0mm 12.0mm, 14.0mm
Catalog Number
SSC 2008
Brand Name
DIO BIOTITE-H IMPLANT SYSTEMS
Version/Model Number
SSC 2008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2022
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
-
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
e29e7b50-c93c-45b8-a18f-dcffad687a4a
Public Version Date
February 28, 2022
Public Version Number
4
DI Record Publish Date
January 20, 2016
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 |