Duns Number:316133664
Device Description: Self-etching and dual-curing bonding system. Bonding of composite, compomer or resin-modif Self-etching and dual-curing bonding system. Bonding of composite, compomer or resin-modified glass ionomer cements with enamel and dentin. Used in dentistry
Catalog Number
75250
Brand Name
E-Bond DC
Version/Model Number
75250
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
K042614
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
2fb2a11f-c600-410c-aba8-fbe027e6531e
Public Version Date
June 29, 2020
Public Version Number
2
DI Record Publish Date
June 10, 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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |