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Orthodontic Software
FDA product code PNN · Class 2 · Dental
55
Registered devices
1
Adverse events
2
Recalls
36
510(k) clearances
Devices with this code
NemoCast — SOFTWARE NEMOTEC SLuLab Systems uDesign — Ulab Systems, Inc.uLab Systems uDesign — Ulab Systems, Inc.uLab Systems uDesign — Ulab Systems, Inc.uLab Systems uDesign — Ulab Systems, Inc.Ortho System — 3shape A/SRAYDENT SW — Ray Co., LtduLab Systems uDesign — Ulab Systems, Inc.uLab Systems uDesign — Ulab Systems, Inc.CS Model+ — CARESTREAM DENTAL LLCCS MODEL+ — Dental Imaging Technologies CorporationuLab Systems uDesign — Ulab Systems, Inc.Orchestrate 3D — PARK DENTAL RESEARCH CORPInbrace Teeth Straightening System — SWIFT HEALTH SYSTEMS INC.Automate — 3shape A/SOrtho System — 3shape A/SProgressive Orthodontics App — PROGRESSIVE AMERICA, INC.Arcad Aligners — ARCADLABOrchestrate 3D — Orchestrate 3dMARPE — Great Lakes Dental Technologies, Ltd.Archform Orthodontic Software — Archform Inc.Progressive Orthodontics App — PROGRESSIVE AMERICA, INC.Ortho System — 3shape A/S3Shape Ortho System — 3shape A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-05 | Align Technology Inc | 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor request |
| 2021-11-11 | Orchestrate Orthodontic Technologies, Inc. | Due to product label/labeling being altered from it's approved state. |
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