Duns Number:687789453
Device Description: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
Catalog Number
4008-1140
Brand Name
D-LUX+
Version/Model Number
BATTERY PACK
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
K200809
Product Code
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
3d15b6a7-f2a3-43a1-886e-c29bec57f384
Public Version Date
August 27, 2021
Public Version Number
1
DI Record Publish Date
August 19, 2021
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 | 4806 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |