Duns Number:945015758
Device Description: 11mm Abutment Cutting Bur
Catalog Number
260-201-011
Brand Name
Bur
Version/Model Number
260-201-011
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EJL
Product Code Name
Bur, Dental
Public Device Record Key
accd46b2-7493-43dd-8351-6a0726a13358
Public Version Date
March 24, 2020
Public Version Number
4
DI Record Publish Date
June 10, 2016
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 | 264 |
2 | A medical device with a moderate to high risk that requires special controls. | 421 |