KMYClass 1
Positioner, Tooth, Preformed
FDA adverse event reports and recall history for positioner, tooth, preformed (product code KMY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,667
- Deaths
- 0
- Injuries
- 1,512
- Malfunctions
- 153
Reports per year
309
210
311
212
213
215
216
518
319
7121
1922
423
37624
45925
70626
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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