Duns Number:480017482
Device Description: BRILLIANT Crios Sample KitSample kit consisting of BRILLIANT Crios blocks and ONE COAT 7 U BRILLIANT Crios Sample KitSample kit consisting of BRILLIANT Crios blocks and ONE COAT 7 UNIVERSAL bond.
Catalog Number
60020037
Brand Name
BRILLIANT Crios
Version/Model Number
60020037
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"
Yes
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
38c99d40-dcbc-43b7-b45e-576159a57634
Public Version Date
April 26, 2019
Public Version Number
1
DI Record Publish Date
April 18, 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 | 1524 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 960 |