Duns Number:436661136
Device Description: ENACEM Z KIT PRIMER + CEMENT1 CPCZ ENACEM Z zirconia cement 8g.1 CPCZP ENACEM Z Primer 5 m ENACEM Z KIT PRIMER + CEMENT1 CPCZ ENACEM Z zirconia cement 8g.1 CPCZP ENACEM Z Primer 5 ml.
Catalog Number
CPCZK
Brand Name
EnaCem Z
Version/Model Number
CPCZK
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062355
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
514f8168-252a-4637-892d-8ed6a97998f7
Public Version Date
December 10, 2021
Public Version Number
1
DI Record Publish Date
December 02, 2021
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |