FDA Product Code
FDA Product Code PNN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5470
510(k) Clearances — 35 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262196 | Invisalign System | Align Technology, Inc. | 2026-09-25 | Traditional | PDF ↗ |
| K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026-05-08 | Traditional | PDF ↗ |
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026-03-04 | Traditional | PDF ↗ |
| K252507 | SmileInspector | Amv Consulting, LLC | 2026-01-07 | Traditional | PDF ↗ |
| K253343 | Celebrace Software | Celebrace | 2025-12-29 | Traditional | PDF ↗ |
| K250198 | Laon Ortho | Laon Medi, Inc. | 2025-04-23 | Traditional | PDF ↗ |
| K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | 2024-10-11 | Traditional | PDF ↗ |
| K233625 | RAYDENT SW | Ray Co., Ltd. | 2024-05-16 | Traditional | PDF ↗ |
| K232564 | Align Studio | Laon Medi, Inc. | 2024-03-12 | Traditional | PDF ↗ |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | 2024-01-11 | Traditional | PDF ↗ |
| K232549 | NemoCast | Software Nemotec S.L. | 2023-11-21 | Traditional | PDF ↗ |
| K232429 | Titan Dental Design | Clearadvance, LLC | 2023-10-13 | Traditional | PDF ↗ |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | 2023-06-13 | Traditional | PDF ↗ |
| K212173 | HDH Treatment Planning System | Cdb Corporation | 2022-01-25 | Traditional | PDF ↗ |
| K212770 | Vision | Softsmile, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K213916 | ArchForm Orthodontic Software System | Archform, Inc. | 2021-12-16 | Traditional | PDF ↗ |
| K212828 | BRIUS Planner Software | Brius Technologies, Inc. | 2021-10-01 | Special | PDF ↗ |
| K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | 2021-02-19 | Traditional | PDF ↗ |
| K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | 2020-12-22 | Traditional | PDF ↗ |
| K192847 | AUTOLIGN | Diorco Co., Ltd. | 2020-07-21 | Traditional | PDF ↗ |
| K200772 | ULab Systems uDesign Software | Ulab Systems, Inc. | 2020-06-23 | Traditional | PDF ↗ |
| K193003 | NemoCast | Software Nemotec S.L. | 2020-06-05 | Traditional | PDF ↗ |
| K192701 | DIBS (Digital Indirect Bonding System) | Orthoselect, LLC | 2020-04-21 | Traditional | PDF ↗ |
| K191720 | BRUIS Software Suite | Mechanodontics, Inc. | 2020-04-17 | Traditional | PDF ↗ |
| K193390 | CS Model+ | Trophy | 2020-04-02 | Traditional | PDF ↗ |
| K191911 | 3Shape Splint Design | 3Shape A/S | 2019-11-27 | Traditional | PDF ↗ |
| K183695 | OrthoAnalysis Software | Inteware Co., Ltd. | 2019-09-12 | Traditional | PDF ↗ |
| K181112 | Orchestrate 3D | Orchestrate 3D | 2018-11-26 | Traditional | PDF ↗ |
| K180941 | Ortho System | 3Shape A/S | 2018-10-17 | Traditional | PDF ↗ |
| K171634 | Ortho System | 3Shape A/S | 2018-01-17 | Special | PDF ↗ |
| K171122 | CEREC Ortho Software | Dentsply Sirona | 2018-01-11 | Traditional | PDF ↗ |
| K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018-01-09 | Traditional | PDF ↗ |
| K163677 | Ortho System | 3Shape A/S | 2017-04-20 | Traditional | PDF ↗ |
| K162850 | GuideMia Ortho+ | Guidemia Technologies, LLC | 2017-03-24 | Traditional | PDF ↗ |
| K152086 | 3Shape Ortho System | 3Shape A/S | 2016-04-28 | Traditional | PDF ↗ |
Product code PNN · Class II · Dental. Data: openFDA.