Duns Number:063005260
Device Description: The material is an alternative to traditional dental prostheses material. SprintRay OnX To The material is an alternative to traditional dental prostheses material. SprintRay OnX Tough resin is intended exclusively for professional dental work.
Catalog Number
SRI-0202071
Brand Name
OnX Tough - Hollywood Bleach
Version/Model Number
SRI-0202071
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
ELJ
Product Code Name
Teeth, Artificial, Posterior With Metal Insert
Public Device Record Key
9a44234f-3140-489f-85b5-8bb042c92434
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
Package DI Number
10850039704175
Quantity per Package
1
Contains DI Package
00850039704178
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |