Duns Number:113170088
Device Description: Bend A Brushes are intended for use in the application of dental resins, sealants and etch Bend A Brushes are intended for use in the application of dental resins, sealants and etchants to the tooth surface.
Catalog Number
BB50
Brand Name
Bend A Brush
Version/Model Number
BB50
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
-
Product Code
KXR
Product Code Name
Applicator, Resin
Public Device Record Key
398c8e8d-dc8a-44d0-a5da-83e9dd780779
Public Version Date
November 08, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
Package DI Number
D798BB502
Quantity per Package
250
Contains DI Package
D798BB501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |