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Align Technology, Inc. · Model SW-0000159 · UDI-DI 00816063021360
PNN
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
41
Facilities
Description
3D Treatment Planning Software - ClinCheck Pro 6
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 requested) and incorrect pa |
| 2021-11-11 | Orchestrate Orthodontic Technologies, Inc. | Due to product label/labeling being altered from it's approved state. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.