Duns Number:316699578
Device Description: Profibase is a light-curing resin in pre-contoured plates for maxillae and mandiblesfor th Profibase is a light-curing resin in pre-contoured plates for maxillae and mandiblesfor the fabrication of individual impression and functional trays for use in crown,bridge and total prosthetic technique to be used for the fabrication of bases of bitepatterns as well as for dimensionally stable base plates for wax contouring in thetotal prosthetic technique.The material is ready for use and easy to handle.
Catalog Number
2113
Brand Name
Profibase
Version/Model Number
2113
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
e67f1ced-6683-4a28-bdaa-1b9aea561bea
Public Version Date
June 14, 2019
Public Version Number
1
DI Record Publish Date
June 06, 2019
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |