Duns Number:113170088
Device Description: Perfect A Smile Pontic Paint is intended for use as a light cure coloring agent of thermop Perfect A Smile Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. This patented formula works with clear thermoforming aligner plastics. It is not recommended for use with cloudy (C) thermoforming materials.
Catalog Number
PPb1
Brand Name
Perfect A Smile
Version/Model Number
PPB1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K130237
Product Code
NXC
Product Code Name
Aligner, Sequential
Public Device Record Key
731bac96-d7ee-43c1-8423-615cfe5425dd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 06, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |