Duns Number:315830349
Device Description: Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobal Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and relining dentures
Catalog Number
-
Brand Name
FuturaPress HP Pink Transparent
Version/Model Number
650420
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
72d0e7d3-aedf-43c5-8f12-f315d6cf804f
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 13, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 390 |