Duns Number:001006089
Device Description: 6 mL bottle, clear shade, brush handle, 100 brush tipsPenetrating Finish and Polishing Res 6 mL bottle, clear shade, brush handle, 100 brush tipsPenetrating Finish and Polishing Resin, Light Cure
Catalog Number
-
Brand Name
EMBRACE WETBOND SEAL-N-SHINE
Version/Model Number
EMSNS
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K020432
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
30f67a3a-a582-4e78-9191-0d9ff2894695
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 28, 2016
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |