Duns Number:320744915
Device Description: Glass fiber-reinforced pre-silanized composite root post. The DMG quality root post. Conte Glass fiber-reinforced pre-silanized composite root post. The DMG quality root post. Content: 5 posts (pre-silanized, Ø 1.5 mm ).
Catalog Number
110783
Brand Name
LuxaPost
Version/Model Number
110783
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
ELR
Product Code Name
Post, Root Canal
Public Device Record Key
c4d78795-830c-42c4-a537-b419a183ed75
Public Version Date
September 09, 2022
Public Version Number
1
DI Record Publish Date
September 01, 2022
Package DI Number
EDMG1107831
Quantity per Package
1
Contains DI Package
EDMG1107830
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |