Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed) | PA 19 021

Opportunity Information: Apply for PA 19 021

The grant opportunity titled "Advancing Imaging, Device Production, and Clinical Capabilities in Digital Dentistry (R41/R42 Clinical Trial Not Allowed)" is a National Institutes of Health (NIH) small business funding announcement designed to push forward the practical technologies that underpin modern digital dentistry. It focuses on improving how oral health care is delivered by making workflows more efficient, sharpening clinical decision-making, and ultimately improving treatment outcomes related to dental, oral, and craniofacial (DOC) tissues. In plain terms, the program is looking for innovations that help dentists and specialists capture better information, turn that information into actionable plans, and produce dental devices and restorations more reliably and effectively using digital tools.

A central theme of the announcement is the advancement of digital imaging and image processing for dental radiology. This includes efforts that improve how images are acquired, enhanced, analyzed, and interpreted, with an emphasis on tools that can make imaging more clinically useful, more integrated into care pathways, and more consistent across different settings. Projects might target better imaging quality, improved reconstruction or segmentation methods, smarter visualization, or other image processing capabilities that support diagnosis and treatment planning. The intent is not imaging for imaging's sake, but imaging that feeds into clearer decisions and better outcomes for conditions involving DOC structures.

Another major area of interest is integrating 3D additive manufacturing, such as 3D printing, with imaging tools and digital dentistry workflows. The FOA encourages work that connects scan-to-design-to-fabrication pipelines, where imaging data can be translated into precise physical devices or restorations. This can include technological improvements that make fabrication faster, more accurate, more customizable to individual patients, or easier to implement in clinical and laboratory environments. The emphasis on integration signals that NIH is interested in end-to-end systems and interoperable components, not just isolated advances.

The announcement also explicitly supports development, integration, adaptation, optimization, and validation of dental materials intended for additive manufacturing. That means the program is open not only to new materials but also to improving existing ones so they perform well in 3D printing and related manufacturing approaches. The supported scope includes materials and processes used in repair, replacement, and restoration of DOC tissues, which can cover a wide range of restorative and reconstructive applications. The inclusion of validation highlights that applicants should be thinking beyond early concepts and toward evidence that a material or process works as intended in relevant use conditions, even though clinical trials are not allowed under this specific FOA.

From an administrative and eligibility standpoint, this is an NIH discretionary grant opportunity aligned with the Small Business Innovation Research (SBIR) mechanism, specifically R41/R42. That structure generally corresponds to a phased approach, where Phase I (R41) supports early feasibility and proof-of-concept work and Phase II (R42) supports more advanced research and development aimed at commercialization readiness. The activity area is health, and the referenced CFDA number is 93.121. The eligible applicant pool is limited to small businesses, reflecting the SBIR focus on translating innovations into deployable products and capabilities.

The FOA carries important restrictions related to foreign involvement. Non-U.S. entities (foreign institutions) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components may be allowed in some cases as defined by the NIH Grants Policy Statement, meaning limited, well-justified international elements might be permissible depending on how they fit NIH rules. Applicants are expected to consult the full funding announcement for the exact boundaries of what is and is not allowable regarding foreign components.

Key identifying details from the source information include the funding opportunity number PA 19 021, the sponsoring agency (National Institutes of Health), and an original closing date listed as 2021-09-05. The opportunity was created on 2018-10-09. The listing does not specify an award ceiling or expected number of awards in the provided fields, so applicants would need to consult the full announcement or NIH guidance to understand budget expectations, typical award sizes, and submission cycles if the announcement has been reissued or maintained through later due dates. Overall, the program is aimed at small businesses with strong technical and translational plans to improve digital dentistry through better imaging, better integration with additive manufacturing, and better printable materials for restoring and repairing DOC tissues, while staying within the boundary that clinical trials are not permitted under this FOA.

• 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 (R41/R42 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 19 021

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