Duns Number:152165700
Device Description: Whitening Handpiece is intended for use with Biolase diode laser systems such as Epic X or Whitening Handpiece is intended for use with Biolase diode laser systems such as Epic X or Epic Pro and LaserWhite20 Whitening Gel for laser-assisted tooth whitening procedures. The handpiece is reusable and requires disinfection prior to use. The handpiece is equipped with with single-use disposable protective shields included in the packaging in a set of 5.
Catalog Number
7400022
Brand Name
Diode Laser System Whitening Handpiece
Version/Model Number
7400022
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
K121286,K121286
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
093de688-02f2-441c-8231-923a0606e303
Public Version Date
July 29, 2020
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
00647529003725
Quantity per Package
1
Contains DI Package
00647529000205
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |