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KMYClass 1

Positioner, Tooth, Preformed

FDA adverse event reports and recall history for positioner, tooth, preformed (product code KMY), from the public MAUDE corpus and the live FDA recall database.

Total reports
1,674
Deaths
0
Injuries
1,519
Malfunctions
153

Reports per year

09
10
11
12
13
15
16
18
19
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20092026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

No recalls listed in the FDA device recall database for this entry.

Monitor positioner, tooth, preformed automatically

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