Orthodontic Software
Regulation 872.5470
7510(k)s in 12 months (37 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PNN
| Company | 510(k)s | Recalls |
|---|---|---|
| 3Shape A/S | 5 | 0 |
| Align Technology, Inc. | 1 | 1 |
| Dentsply Sirona | 2 | 0 |
| Laon Medi, Inc. | 2 | 0 |
| Software Nemotec S.L. | 2 | 0 |
| Ulab Systems, Inc. | 2 | 0 |
| Amv Consulting, LLC | 1 | 0 |
| Archform, Inc. | 1 | 0 |
| Brius Technologies, Inc. | 1 | 0 |
| Cdb Corporation | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2023 | Align Technology Inc Invisalign Express 10 REF 8512
Invisalign System Comprehensive REF 9000
Invisalign System Moderate REF 9001 Completed |
PNN | K220287 |
| Nov 11, 2021 | Orchestrate Orthodontic Technologies, Inc. O3D ORCHESTRATE Orthodontic Technologies
User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1
for Orchestrate3d Software v.3.1 - v5.0.4 Terminated |
PNN | K181112 |
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