Duns Number:036623932
Device Description: Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementa Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementation or repairs. Standard kit includes (2) 1.2mL prefilled etch syringes, (2) 1.2mL prefilled silane syringes, (25) Spira-Flo™ brush tips
Catalog Number
-
Brand Name
Porcelain Etch
Version/Model Number
502500
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
K933766,K933766
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
ef1e32fe-4d83-4251-bfe8-5925b9b36882
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
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 | 316 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |
| U | Unclassified | 36 |