Duns Number:687789453
Device Description: DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dent DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.
Catalog Number
A2001-2101
Brand Name
DiaPlus
Version/Model Number
DiaPlus 5ml
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
K192392
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
cf8560f9-6442-4f85-9892-37541a866f71
Public Version Date
August 21, 2020
Public Version Number
1
DI Record Publish Date
August 13, 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 |