Duns Number:688322841
Device Description: Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiop Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide.
Catalog Number
-
Brand Name
Nexcomp Unidose B2E
Version/Model Number
9458
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
-
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
2b995a97-34bd-48e6-9f57-99ad94e84b9a
Public Version Date
October 18, 2021
Public Version Number
3
DI Record Publish Date
November 30, 2018
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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |