Duns Number:688731057
Device Description: Used to remove dental calculus. Also, it is used to remove foreign substances in the middl Used to remove dental calculus. Also, it is used to remove foreign substances in the middle to apical area of the root canal.
Catalog Number
-
Brand Name
Ultrasonic Tip 0.3mm (BUST-03)
Version/Model Number
BUST-03
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)
-
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
abd55f48-d0e6-4bd5-9490-c2e951d4d22d
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 01, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |