Duns Number:789664455
Device Description: Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and Acclaim is a highly polishable, self cure, paste/paste, Bis-GMA composite for anterior and posterior restorations. Material exhibits; high mechanical strength and excellent marginal adaptation. High filler content contributes to low shrinkage, low water sorption, low coefficient of thermal expansion and good wear and scratch resistance. Acclaim has a very good x-ray opacity, outstanding color stability and resistance to staining.
Catalog Number
1012
Brand Name
Acclaim Chemical Cure Composite Restorative Material
Version/Model Number
1012
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
850b2773-f381-4d63-8701-9ecbc3a3a978
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 02, 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 |