Duns Number:113170088
Device Description: For the indirect technique, bonding large acrylic appliances and lingual appliances. This For the indirect technique, bonding large acrylic appliances and lingual appliances. This is a 6gm syringe of Excel Regular Part A Non Fluoride.
Catalog Number
1ERSA
Brand Name
EXCEL
Version/Model Number
1ERSA
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
K875141
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
c62741fc-235d-4528-adde-34a4066624df
Public Version Date
March 22, 2019
Public Version Number
1
DI Record Publish Date
March 14, 2019
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |