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Talk to a SpecialistTalk to a SpecialistVitang Technology LLC, a manufacturer and distributor of the UniSmile Clear Aligner System (a Class II dental device cleared via 510(k)), was cited for marketing a misbranded and/or unapproved device in violation of CGMP and Quality System Regulation requirements. During a January 2023 FDA inspection, investigators determined the firm had made undisclosed changes to the cleared device, including modifications to the software component (Orchestrate 3D/OrthoRx software) without appropriate regulatory approval or documentation. The company's February 2023 response to the FDA 483 observations was found to be inadequate in addressing these material violations.