Duns Number:054012763
Device Description: Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, reta Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, retainers, mouthguards, nightguards, TMJ appliances, water flosser tips, and more.
Catalog Number
-
Brand Name
Smile Spa
Version/Model Number
100-0367
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLG
Product Code Name
Cleaner, Ultrasonic, Medical Instrument
Public Device Record Key
eb6159a6-0439-496c-925e-1e73c5a7057f
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
August 19, 2019
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |