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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mouthguard, over-the-counter
Definition To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Product CodeOBR
Device Class Unclassified

Device Problems
Delamination 695
No Known Device Problem 3
Size incorrect for patient 3
User used incorrect product for intended use 2
Manufacturing or shipping issue associated with device 2
Use of Device Issue 2
Product quality issue 1
Torn material 1
Misassembled by Users 1
Total Device Problems 710

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