Orthodontic Software
Regulation 872.5470
7510(k)s in 12 months (37 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PNN
| Company | 510(k)s | Recalls |
|---|---|---|
| 3Shape A/S | 5 | 0 |
| Align Technology, Inc. | 1 | 1 |
| Dentsply Sirona | 2 | 0 |
| Laon Medi, Inc. | 2 | 0 |
| Software Nemotec S.L. | 2 | 0 |
| Ulab Systems, Inc. | 2 | 0 |
| Amv Consulting, LLC | 1 | 0 |
| Archform, Inc. | 1 | 0 |
| Brius Technologies, Inc. | 1 | 0 |
| Cdb Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2026 | K260421 | LuxDesign LuxCreo, Inc. | PNN |
| Oct 7, 2026 | K262378 | Dr.AlignNavi InnoDtech, Inc., KR | PNN |
| Sep 25, 2026 | K262196 | Invisalign System Align Technology, Inc. | PNN |
| May 8, 2026 | K260419 | LingOral Dental Design System Hangzhou ChohoTech Co., Ltd., CN | PNN |
| Mar 4, 2026 | K253565 | SureSmile Software Dentsply Sirona, Inc. | PNN |
| Jan 7, 2026 | K252507 | SmileInspector Amv Consulting, LLC | PNN |
| Dec 29, 2025 | K253343 | Celebrace Software Celebrace | PNN |
| Apr 23, 2025 | K250198 | Laon Ortho Laon Medi, Inc., KR | PNN |
| Oct 11, 2024 | K241153 | Progressive Orthodontics App Progressive Aligners, Inc. | PNN |
| May 16, 2024 | K233625 | RAYDENT SW Ray Co., Ltd., KR | PNN |
| Mar 12, 2024 | K232564 | Align Studio Laon Medi, Inc., KR | PNN |
| Jan 11, 2024 | K233616 | Clevaligner Software (V1.0.0) Clevaligner, Ltd., IL | PNN |
| Nov 21, 2023 | K232549 | NemoCast Software Nemotec S.L., ES | PNN |
| Oct 13, 2023 | K232429 | Titan Dental Design Clearadvance, LLC | PNN |
| Jun 13, 2023 | K223518 | iOrtho Shanghai EA Medical Instruments Co., Ltd., CN | PNN |
| Jan 25, 2022 | K212173 | HDH Treatment Planning System Cdb Corporation | PNN |
| Dec 21, 2021 | K212770 | Vision Softsmile, Inc. | PNN |
| Dec 16, 2021 | K213916 | ArchForm Orthodontic Software System Archform, Inc. | PNN |
| Oct 1, 2021 | K212828 | BRIUS Planner Software Brius Technologies, Inc. | PNN |
| Feb 19, 2021 | K203442 | Inbrace Orthodontic System Swift Health Systems, Inc. | PNN |
| Dec 22, 2020 | K201036 | PlaniMax Orthodontic Software Choice Biotech, Inc., TW | PNN |
| Jul 21, 2020 | K192847 | AUTOLIGN Diorco Co., Ltd., KR | PNN |
| Jun 23, 2020 | K200772 | ULab Systems uDesign Software Ulab Systems, Inc. | PNN |
| Jun 5, 2020 | K193003 | NemoCast Software Nemotec S.L., ES | PNN |
| Apr 21, 2020 | K192701 | DIBS (Digital Indirect Bonding System) Orthoselect, LLC | PNN |
| Apr 17, 2020 | K191720 | BRUIS Software Suite Mechanodontics, Inc. | PNN |
| Apr 2, 2020 | K193390 | CS Model+ Trophy, FR | PNN |
| Nov 27, 2019 | K191911 | 3Shape Splint Design 3Shape A/S, DK | PNN |
| Sep 12, 2019 | K183695 | OrthoAnalysis Software Inteware Co., Ltd., CN | PNN |
| Nov 26, 2018 | K181112 | Orchestrate 3D Orchestrate 3D | PNN |
| Oct 17, 2018 | K180941 | Ortho System 3Shape A/S, DK | PNN |
| Jan 17, 2018 | K171634 | Ortho System 3Shape A/S, DK | PNN |
| Jan 11, 2018 | K171122 | CEREC Ortho Software Dentsply Sirona | PNN |
| Jan 9, 2018 | K171295 | ULab Systems Treatment Planning Software Ulab Systems, Inc. | PNN |
| Apr 20, 2017 | K163677 | Ortho System 3Shape A/S, DK | PNN |
| Mar 24, 2017 | K162850 | GuideMia Ortho+ Guidemia Technologies, LLC | PNN |
| Apr 28, 2016 | K152086 | 3Shape Ortho System 3Shape A/S, DK | PNN |
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