Duns Number:341086190
Device Description: crea.lign paste Dentin A1 Light curing composite nanofilled 3 g
Catalog Number
CLPNDA10
Brand Name
crea.lign paste Dentin A1
Version/Model Number
CLPNDA10
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
607ba725-f8e4-46b2-9d13-236ccc563f7d
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
EBRECLPNDA109
Quantity per Package
1
Contains DI Package
EBRECLPNDA100
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 |