Duns Number:381582196
Device Description: The AutoFocus by ActeonThe power density (number of photons) of a lamp decreasessignifican The AutoFocus by ActeonThe power density (number of photons) of a lamp decreasessignificantly the farther away it is from the composite. Toensure effective polymerization, the exposure time wouldneed to be calculated for each clinical procedure,according the position of the tooth, and even the shapeof the composite.The AutoFocus function is an “active” systemwhich enables automatic calculation of the time,and therefore of the ideal power density,requiredfordeep polymerization ofcomposites, whatever menu is selected. Thiswill avoid under or overexposure of time andstop any inflammation..
Catalog Number
F05302
Brand Name
ACTEON
Version/Model Number
HANDPIECE MINILED AF2 OEM
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
K072181
Product Code
EBZ
Product Code Name
Activator, Ultraviolet, For Polymerization
Public Device Record Key
801b7b5b-1005-4cde-acf8-0bbec7d486e7
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 |