Product code PNN
- Device name
- Orthodontic Software
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5470
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026-05-08 |
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026-03-04 |
| K252507 | SmileInspector | Amv Consulting, LLC | 2026-01-07 |
| K253343 | Celebrace Software | Celebrace | 2025-12-29 |
| K250198 | Laon Ortho | Laon Medi, Inc. | 2025-04-23 |
| K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | 2024-10-11 |
| K233625 | RAYDENT SW | Ray Co., Ltd. | 2024-05-16 |
| K232564 | Align Studio | Laon Medi, Inc. | 2024-03-12 |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | 2024-01-11 |
| K232549 | NemoCast | Software Nemotec S.L. | 2023-11-21 |
| K232429 | Titan Dental Design | Clearadvance, LLC | 2023-10-13 |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | 2023-06-13 |
| K212173 | HDH Treatment Planning System | Cdb Corporation | 2022-01-25 |
| K212770 | Vision | Softsmile, Inc. | 2021-12-21 |
| K213916 | ArchForm Orthodontic Software System | Archform, Inc. | 2021-12-16 |
| K212828 | BRIUS Planner Software | Brius Technologies, Inc. | 2021-10-01 |
| K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | 2021-02-19 |
| K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | 2020-12-22 |
| K192847 | AUTOLIGN | Diorco Co., Ltd. | 2020-07-21 |
| K200772 | ULab Systems uDesign Software | Ulab Systems, Inc. | 2020-06-23 |
| K193003 | NemoCast | Software Nemotec S.L. | 2020-06-05 |
| K192701 | DIBS (Digital Indirect Bonding System) | Orthoselect, LLC | 2020-04-21 |
| K191720 | BRUIS Software Suite | Mechanodontics, Inc. | 2020-04-17 |
| K193390 | CS Model+ | Trophy | 2020-04-02 |
| K191911 | 3Shape Splint Design | 3Shape A/S | 2019-11-27 |
| K183695 | OrthoAnalysis Software | Inteware Co., Ltd. | 2019-09-12 |
| K181112 | Orchestrate 3D | Orchestrate 3D | 2018-11-26 |
| K180941 | Ortho System | 3Shape A/S | 2018-10-17 |
| K171634 | Ortho System | 3Shape A/S | 2018-01-17 |
| K171122 | CEREC Ortho Software | Dentsply Sirona | 2018-01-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D775BMARPEL0 | MARPE | Great Lakes Dental Technologies, Ltd. | 2026-05-10 |
| D775BMARPEP0 | MARPE | Great Lakes Dental Technologies, Ltd. | 2026-05-10 |
| 06977207040662 | Angel Aligner | Shanghai EA Medical Instruments Co., Ltd. | 2026-05-08 |
| 08437023642016 | NemoCast | SOFTWARE NEMOTEC SL | 2026-04-23 |
| 00810060227053 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2026-04-13 |
| 00860012168521 | Archform Orthodontic Software | Archform Inc. | 2025-07-22 |
| D769O3D0 | Orchestrate 3D | PARK DENTAL RESEARCH CORP | 2025-07-17 |
| 08800026700869 | Medit Orthodontic Suite | Medit Corp. | 2025-05-29 |
| D16420251 | Progressive Orthodontics App | PROGRESSIVE AMERICA, INC. | 2025-04-30 |
| 00810060226346 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2025-02-20 |
| 00860461001776 | uLab Systems uDesign | Ulab Systems, Inc. | 2025-01-28 |
| D16409625 | Progressive Orthodontics App | PROGRESSIVE AMERICA, INC. | 2024-11-07 |
| 00810060226063 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2024-06-19 |
| 08800003005031 | RAYDENT SW | Ray Co., Ltd | 2024-05-23 |
| 00860461001783 | uLab Systems uDesign | Ulab Systems, Inc. | 2024-05-20 |
| 00860009273702 | Vision | Softsmile, Inc. | 2024-02-16 |
| 05902729753913 | Automate | 3shape A/S | 2024-01-22 |
| 00816063021391 | Invisalign Palatal Expander | Align Technology, Inc. | 2024-01-03 |
| 00816063021384 | Invisalign Palatal Holder | Align Technology, Inc. | 2024-01-03 |
| 00860461001769 | uLab Systems uDesign | Ulab Systems, Inc. | 2023-11-02 |
| 00860002380087 | uLab Systems uDesign | Ulab Systems, Inc. | 2022-04-11 |
| 00816063021360 | ClinCheck | Align Technology, Inc. | 2022-02-17 |
| 00860002380070 | uLab Systems uDesign | Ulab Systems, Inc. | 2021-05-10 |
| 00860002380049 | uLab Systems uDesign | Ulab Systems, Inc. | 2020-11-16 |
| 00860002380032 | uLab Systems uDesign | Ulab Systems, Inc. | 2020-07-14 |
| 00860002380025 | uLab Systems uDesign | Ulab Systems, Inc. | 2020-07-10 |
| 00860002380018 | uLab Systems uDesign | Ulab Systems, Inc. | 2020-02-18 |
| 00860002380001 | uLab Systems uDesign | Ulab Systems, Inc. | 2019-09-18 |
| 00815131026726 | Blue Sky Bio, LLC. | BLUE SKY BIO LLC | 2018-10-17 |
| 00860461001707 | uLab Systems uDesign | Ulab Systems, Inc. | 2018-08-20 |