Duns Number:021228671
Device Description: BruxZir NOW Milling Blocks C3 for GL Electric Mills (3-pack)
Catalog Number
70-1167-NOW0029
Brand Name
BruxZir
Version/Model Number
70-1167-NOW0029
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
Yes
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,K130924
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
1c6e86de-9778-4943-994f-a0a8957e58a2
Public Version Date
July 24, 2018
Public Version Number
4
DI Record Publish Date
June 22, 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 |
|---|---|---|
| 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 |