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Orthodontic Software
FDA product code PNN · Class 2 · Dental
48
Registered devices
1
Adverse events
2
Recalls
34
510(k) clearances
Devices with this code
Orchestrate 3D — Orchestrate 3duLab Systems uDesign — Ulab Systems, Inc.3Shape Ortho System — 3shape A/SBlue Sky Bio, LLC. — BLUE SKY BIO LLCCEREC Ortho Software — SIRONA Dental Systems GmbHInbrace Teeth Straightening System — SWIFT HEALTH SYSTEMS INC.Ortho System — 3shape A/SOrchestrate 3D — PARK DENTAL RESEARCH CORPuLab Systems uDesign — Ulab Systems, Inc.CEREC Ortho Software — SIRONA Dental Systems GmbHArcad Aligners — ARCADLABBlue Sky Bio, LLC. — BLUE SKY BIO LLCInbrace Teeth Straightening System — SWIFT HEALTH SYSTEMS INC.uLab Systems uDesign — Ulab Systems, Inc.Blue Sky Bio, LLC. — BLUE SKY BIO LLCuLab Systems uDesign — Ulab Systems, Inc.InBrace Teeth Straightening System (Gen 2.0) — SWIFT HEALTH SYSTEMS INC.ClinCheck — Align Technology, Inc.Progressive Orthodontics App — PROGRESSIVE AMERICA, INC.CEREC Ortho Software — SIRONA Dental Systems GmbHVision — Softsmile, Inc.CS MODEL+ — Dental Imaging Technologies CorporationOrtho System — 3shape A/SuLab Systems uDesign — Ulab Systems, Inc.
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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