Duns Number:315471722
Device Description: SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is availabl SmartLite Focus Battery Pack is a part of the SmartLite Focus Curing Light and is available separately.
Catalog Number
64450021
Brand Name
SmartLite Focus
Version/Model Number
64450021
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EBZ
Product Code Name
ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
Public Device Record Key
74a29048-6b36-413a-a1ff-848df1a82f45
Public Version Date
October 20, 2021
Public Version Number
2
DI Record Publish Date
December 16, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |