Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R43/R44 Clinical Trial Not Allowed) | PA 19 022

Opportunity Information: Apply for PA 19 022

The NIH funding opportunity "Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R43/R44 Clinical Trial Not Allowed)" (PA-19-022) is a Small Business Innovation Research (SBIR) grant program aimed at accelerating practical, commercially relevant technology advances in digital dentistry. Its core purpose is to support small businesses developing or improving tools that make oral healthcare delivery more efficient, help clinicians make better decisions, and ultimately improve treatment outcomes for dental, oral, and craniofacial (DOC) conditions. The focus is on innovation that can meaningfully enhance how dentists and specialists capture, interpret, and use digital information to diagnose problems, plan care, and deliver restorative or reconstructive treatments.

A major emphasis of the announcement is on advancing digital imaging and image processing for dental radiology. This includes technologies that improve acquisition and interpretation of dental images, such as better workflows for 2D and 3D imaging, enhanced reconstruction or post-processing methods, and tools that strengthen diagnostic confidence or reduce ambiguity in clinical decision-making. In practical terms, this can cover improvements that make imaging faster, more accurate, lower dose, easier to integrate into routine practice, or more informative for treatment planning. The FOA is also interested in ways imaging can be paired with downstream digital workflows, so that captured anatomy can be translated more directly into actionable clinical plans.

Another central area is the integration of 3D additive manufacturing (often referred to as 3D printing) with imaging tools and digital dentistry workflows. The FOA encourages projects that connect imaging-derived data to the fabrication of dental devices and components, with an emphasis on improving how patient-specific information is used to produce clinically useful outputs. This can include better end-to-end pipelines from scan to design to manufacture, improvements in device accuracy or fit, and technical advances that make additive manufacturing more reliable and scalable for dental applications. The overarching goal is to tighten the link between digital diagnosis and physical device production, reducing friction in the process and improving consistency in real-world clinical settings.

The announcement also explicitly supports work on dental materials suited for additive manufacturing, including efforts to develop, integrate, adapt, optimize, and validate both new and existing materials for use in repairing, replacing, or restoring DOC tissues. This portion of the FOA recognizes that digital dentistry is not only about scanners and software; it also depends heavily on material performance, manufacturability, and compatibility with clinical requirements. Projects may involve tailoring materials to printing processes, improving mechanical or biological performance for dental applications, or generating the kinds of validation data needed to support adoption and eventual commercialization, as long as the work aligns with the FOA's digital dentistry and additive manufacturing objectives.

From an administrative and eligibility standpoint, this is a discretionary NIH grant opportunity in the health funding category (CFDA 93.121) and is limited to eligible small business applicants, consistent with the R43/R44 mechanism. Importantly, clinical trials are not allowed under this FOA, which generally means applicants should propose technology development and validation activities that do not meet the NIH definition of a clinical trial (for example, engineering development, bench testing, preclinical evaluation, non-clinical usability work, or other forms of validation that do not involve assigning human participants to interventions to evaluate health-related outcomes). The FOA also states that non-U.S. (foreign) institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, "foreign components" as defined by the NIH Grants Policy Statement may be permitted in some cases, meaning limited foreign involvement could be allowable if it meets NIH policy requirements and is appropriately justified, but the applicant organization itself must be a qualifying U.S. small business.

Key identifying details provided include the opportunity number PA-19-022, the administering agency as the National Institutes of Health, and an original closing date listed as 2021-09-05, with the creation date of 2018-10-09. The announcement does not specify an award ceiling or expected number of awards in the provided excerpt, so applicants would typically consult the full FOA for budget guidance, project period limits, and the detailed expectations for Phase I (R43) and Phase II (R44) SBIR activities. Overall, the opportunity is designed to push forward the practical technology backbone of digital dentistry, spanning imaging, software and processing, additive manufacturing integration, and printable dental materials, with an emphasis on improvements that translate into better clinical workflow and better DOC patient care without conducting clinical trials under this mechanism.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R43/R44 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
• This funding opportunity was created on 2018-10-09.
• Applicants must submit their applications by 2021-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PA 19 022

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