Duns Number:315471722
Device Description: SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for SmartLite Focus Intro Package is a cordless pen-style, LED light polymerization device for use by trained dental professionals or dental laboratories. SmartLite Focus is received as a handpiece together with a battery pack. With its supporting accessories (Charging Base, Shields, SmartLite Sleeves, Power Connector) it can be classified as convenience kit.
Catalog Number
64450020
Brand Name
SMARTLITE FOCUS
Version/Model Number
64450020
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
6b8f8e50-90d8-4507-b6e5-260baf5068c3
Public Version Date
October 20, 2021
Public Version Number
3
DI Record Publish Date
March 16, 2017
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 |