Duns Number:607859147
Device Description: Self-cure resin based impression material for the fabrication of temporary crowns and brid Self-cure resin based impression material for the fabrication of temporary crowns and bridges
Catalog Number
-
Brand Name
MatrixTemp Temporary Crown and Bridge Materail
Version/Model Number
103
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
-
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
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
88436c93-d507-46fa-be02-6da859374145
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
October 21, 2016
Package DI Number
10859787002038
Quantity per Package
12
Contains DI Package
00859787002031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |