Duns Number:831465641
Device Description: One Step Adhesive Kit. Contents: 4x5gm syringe, 12ml primer, 7ml liquid etchant, instruct One Step Adhesive Kit. Contents: 4x5gm syringe, 12ml primer, 7ml liquid etchant, instructions, 50 sheet mixing pads, 30x 2" brushes, 2 mixing spatulas.
Catalog Number
-
Brand Name
BONDPRO™ ONE STEP ADHESIVE KIT 4-5gm SYRINGES
Version/Model Number
M961K-01
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
K981036
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
253d6f04-9803-48bc-86a8-69831aea7062
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 288 |