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iTero Lumina Scanning Unit
Align Technology, Inc. · Model 222100 · UDI-DI 00816063022138
NOF
Prescription
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities
Description
Scanning unit (wand)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-15 | CARESTREAM DENTAL, LLC | The mirror may become detached and fall from the unit |
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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.