Duns Number:381582196
Device Description: The MINILED is a curing light using second generation L.E.D technology. It's one of the o The MINILED is a curing light using second generation L.E.D technology. It's one of the only lights able to polymerize almost all types of composite material available today.
Catalog Number
F05400
Brand Name
ACTEON
Version/Model Number
MINILED BLACK
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
K032465
Product Code
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
ca66d5db-1147-4bfb-8618-91200ee1608d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 416 |