Duns Number:307549241
Device Description: Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for w Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials.
Catalog Number
-
Brand Name
EASE-IT
Version/Model Number
20020
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EEG
Product Code Name
Heat Source For Bleaching Teeth
Public Device Record Key
5a9e8d81-f70d-45c8-8361-d040db3c3ed0
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |