Duns Number:689698269
Device Description: Self-Adhesive Universal Resin Cement: Hand-mix 9g(Clear)X1cartridge, mixing padX50ea, spat Self-Adhesive Universal Resin Cement: Hand-mix 9g(Clear)X1cartridge, mixing padX50ea, spatulaX1ea
Catalog Number
-
Brand Name
U-Cem Premium
Version/Model Number
UP109-DC00
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
-
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
37ef243d-a816-4f76-8265-53a3878bae02
Public Version Date
December 30, 2020
Public Version Number
1
DI Record Publish Date
December 22, 2020
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 201 |