Duns Number:113170088
Device Description: Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.
Catalog Number
PPA1
Brand Name
Perfect A Smile
Version/Model Number
PPA1
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
e95bbb9b-1627-434c-bc0e-a656186f7a91
Public Version Date
September 18, 2019
Public Version Number
1
DI Record Publish Date
September 10, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |