Duns Number:113170088
Device Description: The University College Kit includes 1 syringe Ultra Band Lok Blue, 1 syringe Light Bond br The University College Kit includes 1 syringe Ultra Band Lok Blue, 1 syringe Light Bond bracket adhesive, 1 x 2ml bottle Assure Plus Universal Bonding Resin, 1 x Flowtain syringe for lingual retention, Ortho FlexTech and Bond A Braid Lingual retainer wires and Technical Bonding Cards
Catalog Number
UNIVHAND14
Brand Name
College Kit
Version/Model Number
UNIVHAND14
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2016
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
-
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
f8036455-834a-4425-96f7-4f39bdffa879
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 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 |