Duns Number:537713567
Device Description: 3Y-TZP-A zirconium dioxide, pre-sintered white-fired condition. Semi translucent, white-op 3Y-TZP-A zirconium dioxide, pre-sintered white-fired condition. Semi translucent, white-opaque. Suitable for single crowns and/or bridges consisting of up to 16 units. 4-point bending strength: 1200 MPa (typical value)
Catalog Number
3110WNB9095
Brand Name
Nacera
Version/Model Number
Shell 1 for Amann Girrbach
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
-
Product Code
EIH
Product Code Name
Powder, Porcelain
Public Device Record Key
19d7c8db-fa47-40a6-af5d-8da9b757a040
Public Version Date
February 10, 2020
Public Version Number
7
DI Record Publish Date
November 16, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |