Duns Number:537713567
Device Description: Translucent liquid. Increases translucency in the incisal area where applied. Only allowed Translucent liquid. Increases translucency in the incisal area where applied. Only allowed to be used with products of Nacera® Pearl (3Y-TZP).
Catalog Number
4000LQ8030
Brand Name
Nacera
Version/Model Number
Blue X
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092020
Product Code
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
004c561a-1207-4ce4-bde7-a747e57a4b8e
Public Version Date
November 02, 2020
Public Version Number
9
DI Record Publish Date
December 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |