Duns Number:436661136
Device Description: Ena Tender Pink Kit4 colours x 2.5 g:Pink, Pink Dark, Pink Light, Pink Transparent1 Pink P Ena Tender Pink Kit4 colours x 2.5 g:Pink, Pink Dark, Pink Light, Pink Transparent1 Pink Paste Opaque x 1g3 Stain x 3g:White, Blue, Red
Catalog Number
ETPKIT
Brand Name
Ena Tender ®
Version/Model Number
ETPKIT
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
K062906
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
502f77cc-96f6-443e-b829-446457cb8a43
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 15, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |