Duns Number:192699952
Device Description: ORTHQST ORAPRO LC BAND CEM BLUE 1-5G KIT
Catalog Number
-
Brand Name
ORAPRO
Version/Model Number
J301K
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
-
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
4fc16e97-d02a-4f69-a1d9-8d9c2230df63
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
00817713020054
Quantity per Package
6
Contains DI Package
00817713020047
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX J306K
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 222 |