Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PNN — Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
168 daysmedian FDA review time
269 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | 2026-05-08 | 88 | 0 |
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026-03-04 | 107 | 0 |
| K252507 | SmileInspector | Amv Consulting, LLC | 2026-01-07 | 152 | 0 |
| K253343 | Celebrace Software | Celebrace | 2025-12-29 | 90 | 0 |
| K250198 | Laon Ortho | Laon Medi, Inc. | 2025-04-23 | 90 | 0 |
| K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | 2024-10-11 | 168 | 0 |
| K233625 | RAYDENT SW | Ray Co., Ltd. | 2024-05-16 | 185 | 0 |
| K232564 | Align Studio | Laon Medi, Inc. | 2024-03-12 | 201 | 0 |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | 2024-01-11 | 59 | 0 |
| K232549 | NemoCast | Software Nemotec S.L. | 2023-11-21 | 90 | 0 |
| K232429 | Titan Dental Design | Clearadvance, LLC | 2023-10-13 | 63 | 0 |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | 2023-06-13 | 202 | 0 |
| K212173 | HDH Treatment Planning System | Cdb Corporation | 2022-01-25 | 197 | 0 |
| K212770 | Vision | Softsmile, Inc. | 2021-12-21 | 112 | 0 |
| K213916 | ArchForm Orthodontic Software System | Archform, Inc. | 2021-12-16 | 1 | 0 |
| K212828 | BRIUS Planner Software | Brius Technologies, Inc. | 2021-10-01 | 28 | 0 |
| K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | 2021-02-19 | 88 | 0 |
| K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | 2020-12-22 | 246 | 0 |
| K192847 | AUTOLIGN | Diorco Co., Ltd. | 2020-07-21 | 292 | 0 |
| K200772 | ULab Systems uDesign Software | Ulab Systems, Inc. | 2020-06-23 | 90 | 0 |
| K193003 | NemoCast | Software Nemotec S.L. | 2020-06-05 | 221 | 0 |
| K192701 | DIBS (Digital Indirect Bonding System) | Orthoselect, LLC | 2020-04-21 | 207 | 0 |
| K191720 | BRUIS Software Suite | Mechanodontics, Inc. | 2020-04-17 | 295 | 0 |
| K193390 | CS Model+ | Trophy | 2020-04-02 | 118 | 0 |
| K191911 | 3Shape Splint Design | 3Shape A/S | 2019-11-27 | 133 | 0 |
| K183695 | OrthoAnalysis Software | Inteware Co., Ltd. | 2019-09-12 | 255 | 0 |
| K181112 | Orchestrate 3D | Orchestrate 3D | 2018-11-26 | 213 | 0 |
| K180941 | Ortho System | 3Shape A/S | 2018-10-17 | 203 | 0 |
| K171634 | Ortho System | 3Shape A/S | 2018-01-17 | 229 | 0 |
| K171122 | CEREC Ortho Software | Dentsply Sirona | 2018-01-11 | 269 | 0 |
| K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018-01-09 | 252 | 0 |
| K163677 | Ortho System | 3Shape A/S | 2017-04-20 | 114 | 0 |
| K162850 | GuideMia Ortho+ | Guidemia Technologies, LLC | 2017-03-24 | 164 | 0 |
| K152086 | 3Shape Ortho System | 3Shape A/S | 2016-04-28 | 276 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda