Duns Number:332025159
Device Description: Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of perma Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
Catalog Number
RES-01-3185
Brand Name
Flexcera™ Smile Ultra+ A3.5 0.5kg
Version/Model Number
RES-01-3185
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
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
0e15c8bf-312d-47e2-9173-f4395190acca
Public Version Date
January 31, 2022
Public Version Number
1
DI Record Publish Date
January 21, 2022
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 |