Duns Number:081254601
Device Description: Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary de Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings.
Catalog Number
-
Brand Name
Dentemp
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
-
Product Code
EMB
Product Code Name
Zinc Oxide Eugenol
Public Device Record Key
b26ec790-ca10-4522-be5c-9d49bd699462
Public Version Date
March 17, 2022
Public Version Number
1
DI Record Publish Date
March 09, 2022
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |