Duns Number:320744915
Device Description: Self-curing Composite for the fabrication of semipermanent crowns and bridges. The materia Self-curing Composite for the fabrication of semipermanent crowns and bridges. The material is mixed automatically. Content: 1 cartridge @ 50 ml paste, accessories. Color: D2.
Catalog Number
120977
Brand Name
LuxaCrown
Version/Model Number
120977
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
POW
Product Code Name
Crown And Bridge, Long-Term Temporary, Resin
Public Device Record Key
5c44da3d-e40c-4a85-9f14-4ffd6023e720
Public Version Date
June 18, 2019
Public Version Number
1
DI Record Publish Date
June 10, 2019
Package DI Number
EDMG1209771
Quantity per Package
1
Contains DI Package
EDMG1209770
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 |