Duns Number:113170088
Device Description: FlowTain™ is a flowable, light cure orthodontic adhesive intended to be used for bonding l FlowTain™ is a flowable, light cure orthodontic adhesive intended to be used for bonding lingual retainers and splinting materials, creation of archwire stops andindirect bonding of orthodontic brackets and appliances. FlowTain™ can also be used for theretention of thermoplastic aligners. This is a 1.5g syringe of Flow Tain
Catalog Number
1FT
Brand Name
Flow Tain
Version/Model Number
1FT
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
K083051
Product Code
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
495eaa35-5611-4875-b1e6-019a887393e0
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 19, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |