483
Dentlight IncDentlight Inc – FDA 483, Jun 1, 2026
Record Details
An FDA inspection of Dentlight Inc in Plano, TX, a manufacturer of Class IV devices, identified two significant observations. The firm failed to submit required product reports and annual reports for its devices prior to commercial introduction. Additionally, Dentlight Inc did not adequately analyze service records to determine if the information should be handled as a complaint, indicating issues with their complaint handling procedures.
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- Dallas District Office
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ID · 46e85b92-48ad-42bc-806f-1625c4b1eab1
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