Duns Number:320744915
Device Description: Bite registration material automix system. Fresh hardness for optimal occlusion. Content: Bite registration material automix system. Fresh hardness for optimal occlusion. Content: 4 cartridges @50ml paste, Accessories
Catalog Number
999765
Brand Name
O-Bite
Version/Model Number
999765
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"
-
For Single-Use
-
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
K810825,K810825,K810825
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
78df8e94-375d-4348-a40d-949c376b3530
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG9997658
Quantity per Package
6
Contains DI Package
EDMG9997651
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |