Duns Number:137217043
Device Description: Microhybrid composite restorative material. Light-Cure Dental Composite for the aesthetic Microhybrid composite restorative material. Light-Cure Dental Composite for the aesthetic restoration of anterior and posterior teeth. Radiopaque resin based dental restorative material. Shade/color: B3. SDS and Instructions for use available at: https://www.scottsdental.com/catalog/product/view/id/23294/s/microhybrid-composite-compules-scott-s- select/
Catalog Number
199-2336
Brand Name
SCOTT'S SELECT MICROHYBRID COMPULES 15-.3 Gm (B3)
Version/Model Number
199-2336
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
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
677c4dad-da82-46c3-80f6-a70b46b531a4
Public Version Date
August 26, 2020
Public Version Number
5
DI Record Publish Date
May 04, 2017
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 | 1050 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |