Duns Number:001496777
Device Description: Refilit is a Eugenol free temporary dental cement for replacing lost fillings
Catalog Number
-
Brand Name
Refilit
Version/Model Number
1
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K964773,K964773,K964773
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
e320cdbc-6fb5-49e8-b4e5-98d4e6a2ce71
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 27, 2016
Package DI Number
30010705400884
Quantity per Package
16
Contains DI Package
70010705400882
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |