Duns Number:054875224
Device Description: Dynamic Hiossen HG Standard X 9mm Engaging Titanium Base. kit contains . 1 Dynamic Hiossen Dynamic Hiossen HG Standard X 9mm Engaging Titanium Base. kit contains . 1 Dynamic Hiossen HG Standard X 9mm Engaging Titanium Base . 2 Dynamic Hiossen HG Standard Titanium Screw
Catalog Number
9005168
Brand Name
Preat
Version/Model Number
9005168
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
K183518
Product Code
NHA
Product Code Name
Abutment, implant, dental, endosseous
Public Device Record Key
9da9f9e6-3894-4df4-bf16-3de166196480
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 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 | 958 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1846 |