Duns Number:021228671
Device Description: BruxZir Shaded 16 PLUS Milling Blank C4 GD 10mm Z
Catalog Number
70-1185-BXP0207
Brand Name
BruxZir Shaded 16 PLUS
Version/Model Number
70-1185-BXP0207
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
K130924
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
043e7aca-74a2-4eb3-8455-d0dede19df9e
Public Version Date
June 22, 2020
Public Version Number
1
DI Record Publish Date
June 12, 2020
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 | 510 |
2 | A medical device with a moderate to high risk that requires special controls. | 2971 |
U | Unclassified | 2 |