Ethical and regulatory aspects of facial scanning in dentistry: a scoping review

Abstract Objectives To provide an overview of facial scanners and scanning applications used in dentistry, focusing on clinical validation, certification status, and to identify ethical and regulatory concerns. Materials and methods A literature search was performed with eligibility criteria that included studies in dentistry that used at least one facial scanner or smartphone scanning application in human facial region in any language. Scanners and applications identified from literature and International Dental Show 2025 were manually noted, and subsequently searched for detailed certification (medical, general, others) and technical information. Furthermore, studies explicitly/implicitly mention/discuss ethical and/or regulatory concerns were included. Results Ninety-five scanners and 23 smartphone-based applications were identified, of which 90 scanners and all applications were clinically validated. Six scanners (6%, FusionFaceScanner, Carestream CS9600, Planmeca ProFace, Planmeca ProMax 3D Mid, Planmeca ProMax 3D ProFace, Planmeca Viso G7) were Medical Device Regulation-certified, 49% held other certifications, and 51% had unverifiable certification status. Among 19,789 records, six scientific studies discussed ethical concerns, including ethical approval, informed consent, privacy, accuracy, and medical regulatory obligations. Conclusion Despite validation, publicly accessible, verifiable medical-related certification remained limited among the identified scanners, highlighting that ethical and regulatory considerations are underreported in the scientific literature rather than absent from clinical practice. Informed consent, data privacy, accuracy, and medical device compliance were addressed in the included studies. Clinical relevance As facial scans provide comprehensive information for esthetic- and facial-driven treatment planning, the findings of this study highlight the need for practitioners and researchers to remain cautious regarding device safety, regulatory compliance, and technological limitations.