Duns Number:320744915
Device Description: Permanent luting cement automix system. The highlight of restorations. Content: 2 syringes Permanent luting cement automix system. The highlight of restorations. Content: 2 syringes @ 10 g paste, Accessories
Catalog Number
212035
Brand Name
PermaCem Smartmix Dual
Version/Model Number
212035
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
K982895,K982895,K982895
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
5e6a38c4-8dce-4b84-83d2-31f615350fa4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG2120351
Quantity per Package
2
Contains DI Package
EDMG2120350
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 |