Duns Number:332025159
Device Description: Flexcera Base is a light-curing material for the additive manufacturing of individual and Flexcera Base is a light-curing material for the additive manufacturing of individual and removable full denture bases
Catalog Number
RES-01-3140
Brand Name
Flexcera Base Original Pink
Version/Model Number
RES-01-3140
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
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
K203641
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
d55cc57e-73e4-47a7-87e9-28bb0c2e16fc
Public Version Date
May 14, 2021
Public Version Number
1
DI Record Publish Date
May 06, 2021
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |