Duns Number:480420090
Device Description: ZINC OXIDE - 1'000g (regular setting)Temporary filling and root canal sealing (mixed with ZINC OXIDE - 1'000g (regular setting)Temporary filling and root canal sealing (mixed with Eugenol)
Catalog Number
-
Brand Name
ZINC OXIDE - 1'000g
Version/Model Number
11433
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
EMB
Product Code Name
Zinc Oxide Eugenol
Public Device Record Key
576091b4-4591-4553-ba1e-4e72e7cafb5d
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |