Duns Number:341086190
Device Description: crea.lign paste Transpa opal Light curing composite nanofilled 3 g
Catalog Number
CLPN00T1
Brand Name
crea.lign paste Transpa opal
Version/Model Number
CLPN00T1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
7da36b20-969e-4eca-b455-2a8539619bc2
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
March 21, 2019
Package DI Number
EBRECLPN00T19
Quantity per Package
1
Contains DI Package
EBRECLPN00T10
Package Discontinue Date
March 21, 2019
Package Status
Not in Commercial Distribution
Package Type
dummy
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 38 |
2 | A medical device with a moderate to high risk that requires special controls. | 375 |