Duns Number:012430880
Device Description: Natural Elegance is a highly aesthetic light-curing composite resin recommended for restor Natural Elegance is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth.
Catalog Number
5702575
Brand Name
Henry Schein
Version/Model Number
5702575
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
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
-
Product Code
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
95c37a87-d08d-4e0e-95c7-bc0dc5fba4d8
Public Version Date
November 08, 2021
Public Version Number
2
DI Record Publish Date
March 19, 2021
Package DI Number
20304040151970
Quantity per Package
60
Contains DI Package
10304040151973
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |