Duns Number:831465641
Device Description: 37% phosphoric acid gel. A medium viscosity etchant gel used for etching enamel and denin 37% phosphoric acid gel. A medium viscosity etchant gel used for etching enamel and denin prior to bonding procedures.Kit contains 1x 12gm syringe, disposable mixing tips, and instructions.
Catalog Number
-
Brand Name
BONDPRO™ ETCHANT GEL 1-12g KIT
Version/Model Number
M981K-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
98a61310-cc8b-4d67-bed8-8f76521b8723
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 |