Duns Number:081045871
Device Description: 2 pack of 30ml Orange 37% Phosphoric acid etchant gel. Includes 5 empty 1.2ml or 3ml syrin 2 pack of 30ml Orange 37% Phosphoric acid etchant gel. Includes 5 empty 1.2ml or 3ml syringes and connector.
Catalog Number
1601601
Brand Name
e-1 Orange 37% Phosphoric acid etchant gel
Version/Model Number
1601601
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
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
e7a2018c-665d-460f-9ea8-de7f12d54cd4
Public Version Date
April 09, 2018
Public Version Number
1
DI Record Publish Date
March 09, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |