Duns Number:789664455
Device Description: Eagle-Dual-Cure Core Build-Up Material Auto-Mix System• Convenient working time in self-cu Eagle-Dual-Cure Core Build-Up Material Auto-Mix System• Convenient working time in self-cure mode.• Light-cure properties of the material facilitate cure of the product.• Well balanced x-ray opacity permits tooth structure, pins, and posts to be easily distinguishable from material.• Does not require refrigeration; long shelf-life at ambient temperatures.• Significantly saves chair-time due to its auto-mix system.• Intra-oral tips permit application of the material directly into the tooth.
Catalog Number
1020
Brand Name
Eagle-Dual-Cured Core Build-Up Material in Auto-Mix Cartridges
Version/Model Number
1020
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"
Yes
For Single-Use
Yes
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
0d5b9c36-5f3a-45cd-9b6a-71a68791ef5f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |