FDA 510(k) Applications Submitted by Jiahe Li
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200077 |
01/14/2020 |
BioMin Restore Plus |
Dr. Collins, Inc. |
| K250302 |
02/03/2025 |
Flexible Partial Resin |
Prismatik Dentalcraft, Inc. |
| K201182 |
05/01/2020 |
iMask Disposable Surgical Face Mask |
Pac-Dent, Inc. |
| K191308 |
05/14/2019 |
U-Aligner |
Universal Orthodontic Laboratory Inc |
| K231529 |
05/26/2023 |
CloudPoint FastDesign Chairside |
Prismatik Dentalcraft, Inc. |
| K181965 |
07/23/2018 |
Restore Toothpaste |
Dr. Collins, Inc. |
| K202674 |
09/15/2020 |
Medidenta High Speed Handpieces |
Pac-Dent, Inc. |
| K202831 |
09/25/2020 |
The iMask Child's Face Mask |
Pac-Dent, Inc. |
| K202920 |
09/29/2020 |
OptiComp |
Pac-Dent, Inc. |
| K233434 |
10/13/2023 |
Silent Nite« Sleep Appliance with the Glidewell HingeÖ (SNGLHG) |
Prismatik Dentalcraft, Inc |
| K213765 |
12/01/2021 |
Glidewell 3DP Denture Base Resin |
Prismatik Dentalcraft, Inc. |
| K223798 |
12/19/2022 |
Glidewell TuffSplintÖ Appliance Resin |
Prismatik Dentalcraft, Inc. |
| K214102 |
12/29/2021 |
Glidewell Appliance Resin, Hard/Soft |
Prismatik Dentalcraft, Inc. |
|
|
