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iSMILE Dental Aligners
3D DIAGNOSTIX, INC. · Model Orthodontic Aligners · UDI-DI 00850073333006
NXC
Prescription
10
510(k) clearances
18,531
Adverse events (1 deaths)
2
Recalls
99
Facilities
Description
The iSmile is a sequence of transparent aligners created from a digital orthodontic treatment plan. The iSmile aligner is fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivery a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional.
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.