Duns Number:789664455
Device Description: Etch Gel 12 g Syringe with disposable tips, also, available for bulk purchase-1 kg bottle. Etch Gel 12 g Syringe with disposable tips, also, available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. • Convenient dispensing system with disposable tips• Easy to wash off• Economical• Colored for precise application• Excellent wetting characteristics• Non-drying• Direct to tooth application with disposable luer-lock tips• Refillable applicator syringes
Catalog Number
0040
Brand Name
Dental Etchant (Enamel Conditioner), 12g Syringe
Version/Model Number
0040
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"
Yes
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
06c04889-e25c-4fc6-a380-969382e3bd09
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 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. | 59 |