Duns Number:341086190
Device Description: crea.lign Dentin A3.5 Light-curing composite, flowable, nano-ceramic 5 g
Catalog Number
CLFNDA35
Brand Name
crea.lign Dentin A3.5
Version/Model Number
CLFNDA35
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
1de40269-94bc-401d-a53d-9c1f0ea2b6f8
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
EBRECLFNDA359
Quantity per Package
1
Contains DI Package
EBRECLFNDA350
Package Discontinue Date
September 20, 2016
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 |