Duns Number:316699578
Device Description: Light-curing self-etch-bond reinforced with nano-fillers.Chemical-curing in areas inaccess Light-curing self-etch-bond reinforced with nano-fillers.Chemical-curing in areas inaccessible with a curing light.Futurabond DC achieves the same adhesive properties as total-etch preparations without seperate etching of the tooth substance.Moisture-tolerant.Durable marginal integrity.Easy and fast application - one-coat, one-cure technique.contains fluorides.No refrigerated storage needed.Ideal for paediatric use.
Catalog Number
1353
Brand Name
Futurabond M
Version/Model Number
1353
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
-
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
477f17c4-7820-41bb-9a4b-ba9802ad35b5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |