Duns Number:063005260
Device Description: Full arch provisional restoration for all-on-x cases. Denture teeth for removable permanen Full arch provisional restoration for all-on-x cases. Denture teeth for removable permanent full dentures.
Catalog Number
SRI-0202021
Brand Name
OnX - Bleach
Version/Model Number
SRI-0202021
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
88e2f24e-580d-411c-9a86-610f615b9ead
Public Version Date
March 08, 2022
Public Version Number
1
DI Record Publish Date
February 28, 2022
Package DI Number
10850039704076
Quantity per Package
1
Contains DI Package
00850039704079
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 |