Duns Number:001496777
Device Description: Dentemp Custom is a Zinc Oxide / Eugenol temporary dental cement for re-cementing loose ca Dentemp Custom is a Zinc Oxide / Eugenol temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings
Catalog Number
-
Brand Name
DenTemp Custom
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
K821581,K821581,K821581
Product Code
EMB
Product Code Name
Zinc Oxide Eugenol
Public Device Record Key
930a1b61-774c-4c06-a182-d5570d801013
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 27, 2016
Package DI Number
30010705400815
Quantity per Package
24
Contains DI Package
70010705400813
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 |