Duns Number:102422578
Device Description: Removable whitening handpiece sleeve for use with the Precise SHP Diode Laser.
Catalog Number
002-00253
Brand Name
Precise SHP Whitening Handpiece
Version/Model Number
002-00253
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123443
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
d8d65db4-ca6f-4661-9a7a-bea457df6186
Public Version Date
November 08, 2018
Public Version Number
4
DI Record Publish Date
November 10, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |