Duns Number:315830349
Device Description: Cold-curing, methyl methacrylate resinfor adding the saddles to cobalt chrome denture base Cold-curing, methyl methacrylate resinfor adding the saddles to cobalt chrome denture bases, repairs, additions and relines
Catalog Number
-
Brand Name
FuturaPress LT Pink Opaque
Version/Model Number
650122
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
8f472ab6-2ce6-4ce5-ae6a-87add2a76e13
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 12, 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 |