Duns Number:152165700
Device Description: Disposable shields are single-use, non-sterile, clear plastic protective covers intended f Disposable shields are single-use, non-sterile, clear plastic protective covers intended for and specifically designed for use with the Biolase Whitening Handpiece during tooth whitening procedures. The disposable shields fit over the head of the Handpiece and must be discarded after one-time use to avoid cross-contamination between patients.
Catalog Number
6400180
Brand Name
Whitening Handpiece Disposable Shields
Version/Model Number
6400180
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
Yes
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
MMP
Product Code Name
Cover, Barrier, Protective
Public Device Record Key
6047e460-4116-4c10-a52d-876ba2f2a150
Public Version Date
July 29, 2020
Public Version Number
2
DI Record Publish Date
September 25, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |