510(k) K180941
- Device
- Ortho System
- Applicant
- 3Shape A/S
- 510(k) number
- K180941
- Product code
- PNN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-17
- Date received
- 2018-03-28
- Regulation
- 872.5470
- Classification name
- Orthodontic Software
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kristian Worziger Nielsen
- Address
- Holmens Kanal 7 Copenhagen DK 1060 1060
FDA Registration Numbers#
- 3027460334
- 3004884150
- 3014749460
- 3033714666
- 3021233709
- 3028340833
- 3013634985
- 3013342228
- 9680845
- 3016730274
- 3013912897
- 3042369188
- 3012138716
- 3017155477
- 3013508670
- 3007527669
- 3029877582
- 3016446349
- 3010111497
- 1054415
- 3021551875
- 3031606517
- 3008910197
- 3024438491
- 3042204491
- 3015272949
- 3010728558
- 3005695824
- 1316408
- 3003402534
- 3026391019
- 3011471624
- 3025359603
- 1649995
- 3010445368
- 3014680924
- 3025237243
- 3018126402
- 9614977
- 2953749
- 3005940400
Source Documents#
Other 510(k) Records For Product Code PNN #
| 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 |
Legacy Summary#
summary
FDA Review#
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