OrthoFX Aligner
ORTHOFX · Model 019 · UDI-DI 00860003321799
NXC
Prescription
10
510(k) clearances
18,595
Adverse events (1 deaths)
2
Recalls
99
Facilities
Description
Precision Finish Aligner
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | 3M Company - Health Care Business | Attachments may not mate with the tooth as intended in the digital treatment design. |
| 2024-11-04 | Straight Smile, LLC | Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicatio |
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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.