Duns Number:113170088
Device Description: Excel Adhesives are intended for use as an orthodontic bonding adhesive for brackets and Excel Adhesives are intended for use as an orthodontic bonding adhesive for brackets and appliances. This is the Fast Set, self mixing syringe delivery system.
Catalog Number
SMEF
Brand Name
Excel
Version/Model Number
SMEF
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
K875144
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
eb9ccddf-892a-4841-b09d-f1308690651d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 27, 2016
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 |