Duns Number:320744915
Device Description: Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: Self-adhesive dual-cure composite cement. Inseparable. Zirconia and PermaCem 2.0. Content: 1 syringe @ 9 g paste, Accessories. Color: A3 Opaque
Catalog Number
213367
Brand Name
PermaCem 2.0 Self-Adhesive
Version/Model Number
213367
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
K093338,K093338
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
fd2800dd-de4a-4fc1-bae7-cf273bcb7236
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2133671
Quantity per Package
1
Contains DI Package
EDMG2133670
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 |