K183695 is an FDA 510(k) clearance for the OrthoAnalysis Software. This device is classified as a Orthodontic Software (Class II - Special Controls, product code PNN).
Submitted by Inteware Co., Ltd. (Minxiong Township, Chiayi Country 62145, CN). The FDA issued a Cleared decision on September 12, 2019, 255 days after receiving the submission on December 31, 2018.
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 | K183695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2018 |
| Decision Date | September 12, 2019 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| 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. |