Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-11-22 | Z-0743-2025 | Class II | Open, Classified | Attachments may not mate with the tooth as intended in the digital treatment design.Distribution: Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand. | 171 orders | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2014-03-27 | VAI | Voluntary action indicated | 3M Unitek Corporation | 7 |
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