Duns Number:436661136
Device Description: Ena HRi Function Enamel Kit2.5g x 3 colors: EREF1, EREF2, EREF3 Posterior EnamelLight Curi Ena HRi Function Enamel Kit2.5g x 3 colors: EREF1, EREF2, EREF3 Posterior EnamelLight Curing Composite
Catalog Number
ER3FC
Brand Name
Ena HRI ®
Version/Model Number
ER3FC
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
47e523da-a04f-498a-adc6-1f31cd00a397
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 06, 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 |