Duns Number:192699952
Device Description: ORAPRO G2 BAND CEMENT BLUE SYRINGE 5GM
Catalog Number
J910
Brand Name
ORAPRO
Version/Model Number
J910
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
K942596
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
821a560e-f37d-4dc1-8c3f-a5eaeff42df9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 08, 2017
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 222 |