Duns Number:020417380
Device Description: Safco 38% phosphoric acid for etching dentin, enamel and glass ionomer cement
Catalog Number
102-0352
Brand Name
Prep&Etch™
Version/Model Number
102-0352
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
-
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
19410480-d417-4620-b626-4c50e62f6e2b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 17, 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 | 600 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |