Duns Number:152165700
Device Description: laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syring laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Catalog Number
7400030
Brand Name
laserwhite20 Whitening Gel
Version/Model Number
laserwhite20
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
-
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
c1a7ebb0-ea65-44cb-afd6-79ec10edaf9c
Public Version Date
July 29, 2020
Public Version Number
4
DI Record Publish Date
December 13, 2016
Package DI Number
00647529000281
Quantity per Package
5
Contains DI Package
00647529000113
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |