Duns Number:537713567
Device Description: Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zircon Coloring liquid, PEG (Polyethylenglycol) based dye solution. For white pre-sintered zirconium oxide, especially for Nacera® Pearl 1. 16 + 2 shades, 4 effect liquids, balancer, diluting.
Catalog Number
4000LQ8027
Brand Name
Nacera
Version/Model Number
Classic Liquid Effect Blue
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
22c4391e-0358-4474-b46b-6058d388fd22
Public Version Date
November 02, 2020
Public Version Number
8
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 |