K200772 is an FDA 510(k) clearance for the ULab Systems uDesign Software. This device is classified as a Orthodontic Software (Class II - Special Controls, product code PNN).
Submitted by Ulab Systems, Inc. (San Mateo, US). The FDA issued a Cleared decision on June 23, 2020, 90 days after receiving the submission on March 25, 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 | K200772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2020 |
| Decision Date | June 23, 2020 |
| Days to Decision | 90 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. |