K201036 is an FDA 510(k) clearance for the PlaniMax Orthodontic Software. This device is classified as a Orthodontic Software (Class II - Special Controls, product code PNN).
Submitted by Choice Biotech, Inc. (Tainan City, TW). The FDA issued a Cleared decision on December 22, 2020, 246 days after receiving the submission on April 20, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only..
| 510(k) Number | K201036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2020 |
| Decision Date | December 22, 2020 |
| Days to Decision | 246 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PNN - Orthodontic Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only. |