Duns Number:005473608
Device Description: GC Fuji IX GP® Starter Package, A2 (1 x 15g powder, 1 x 6.4mL liquid, 1 x GC CAVITY CONDIT GC Fuji IX GP® Starter Package, A2 (1 x 15g powder, 1 x 6.4mL liquid, 1 x GC CAVITY CONDITIONER, 1 x GC Fuji COAT LC)
Catalog Number
439901
Brand Name
GC Fuji IX GP®
Version/Model Number
439901
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
K951555
Product Code
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
c81dc3b9-c5bf-42d9-b58a-028ed069485a
Public Version Date
July 21, 2022
Public Version Number
1
DI Record Publish Date
July 13, 2022
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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |