Duns Number:687789453
Device Description: Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and de Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.
Catalog Number
A2001-3101
Brand Name
DIAETCH
Version/Model Number
Economic Package Type A
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
K192273
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
8d67def0-97de-4ac7-ae6c-2e8608727f06
Public Version Date
March 04, 2020
Public Version Number
1
DI Record Publish Date
February 25, 2020
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |