Duns Number:320744915
Device Description: Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2 Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2g composite, Accessories. Color: B1
Catalog Number
220704
Brand Name
Constic B1
Version/Model Number
220704
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
K102603,K102603
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
fd7ff18c-2bca-4b05-a16d-18fa0ca5bd9a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2207041
Quantity per Package
2
Contains DI Package
EDMG2207040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |