Duns Number:053308044
Device Description: Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), Chairside rotary tool adjustment kit for crowns. Kit contains discs (LXZW), points (NCFW), and burs (HGDH)
Catalog Number
PKDZLZ
Brand Name
Zubler USA
Version/Model Number
PKDZLZ
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHJ
Product Code Name
Disk, Abrasive
Public Device Record Key
91ebd775-31db-4072-b276-a16f1616baa1
Public Version Date
June 12, 2020
Public Version Number
1
DI Record Publish Date
June 04, 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 | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 1901 |