K212173 is an FDA 510(k) clearance for the HDH Treatment Planning System. This device is classified as a Orthodontic Software (Class II - Special Controls, product code PNN).
Submitted by Cdb Corporation (Leland, US). The FDA issued a Cleared decision on January 25, 2022, 197 days after receiving the submission on July 12, 2021.
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 | K212173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | January 25, 2022 |
| Days to Decision | 197 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. |