Duns Number:600028195
Device Description: Dental Diamond Bur
Catalog Number
Z33RD181
Brand Name
dental diamond bur
Version/Model Number
Z33RD181
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DZP
Product Code Name
Instrument, Diamond, Dental
Public Device Record Key
97de6e45-5398-4ad6-8558-7f3f9f2862b5
Public Version Date
March 23, 2020
Public Version Number
3
DI Record Publish Date
February 11, 2018
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 | 608 |