Duns Number:532176000
Device Description: T-Crystal Thermoplastic Pellets for Dentures by Injection mouldingShade Opaque Pink1kg net T-Crystal Thermoplastic Pellets for Dentures by Injection mouldingShade Opaque Pink1kg net jar
Catalog Number
11009
Brand Name
T-Crystal
Version/Model Number
Opaque Pink
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
f7323687-1734-4a93-a92b-a763a0179e1c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 25, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |