Duns Number:332025159
Device Description: Flexcera Smile is a light-curing material for the additive manufacturing of artificial tee Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
Catalog Number
RES-01-3134
Brand Name
Flexcera Smile A1
Version/Model Number
RES-01-3134
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
PZY
Product Code Name
Additively Manufactured, Preformed, Resin Denture Tooth
Public Device Record Key
6a3a5a83-9420-48d7-8aaa-849735bfde56
Public Version Date
June 30, 2021
Public Version Number
2
DI Record Publish Date
April 19, 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 |