Duns Number:483599259
Device Description: CARES® single unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
Catalog Number
010.4031
Brand Name
Vita CAD-Temp For Inlab
Version/Model Number
Crowns
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K070991
Product Code
EBG
Product Code Name
CROWN AND BRIDGE, TEMPORARY, RESIN
Public Device Record Key
2b2cedcf-52df-4d32-ae9f-7208741a25df
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
July 23, 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 | 52 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2726 |
| 3 | A medical device with high risk that requires premarket approval | 5 |