Next-Generation Restorative Dental Systems for Durable, Safe, Affordable Care

Overview

The RADx® Coordination Center at Cimit, on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of Dental and Craniofacial Research (NIDCR) at the National Institutes of Health (NIH), is soliciting proposals to advance next-generation, mercury-free restorative dental systems that deliver durable clinical performance, affordability, and broad accessibility across different care environments.

Despite substantial progress in dental materials, no widely adopted mercury-free alternative has consistently matched the combined durability, moisture tolerance, operator forgiveness, and cost-effectiveness of dental amalgam, particularly for high-stress posterior restorations and in care settings where time, equipment, and consistent isolation/moisture control (e.g., routine rubber dam use) may be variably achievable. As mercury-containing products are phased down globally and nationally, this gap represents a growing clinical, public health, and operational need. This program prioritizes integrated restorative systems, including restorative material and associated bonding/placement strategy, engineered for reliable performance under real-world constraints, with emphasis on high-caries-burden and resource-constrained settings such as FQHC/Medicaid clinics, mobile and military care environments, and rural practices, where durability, workflow tolerance, and affordability are essential for sustainable adoption.

Leveraging the RADx Tech innovation funnel, this program seeks solutions that are innovation-driven and translation-ready, with a credible path toward independent validation, regulatory alignment, scalable manufacturing, and real-world clinical deployment.

Use-Case Track Selection (required)

Applicants must select one primary use-case track (and may optionally select an additional secondary track) from the choices (Tracks A-E) below to anchor performance targets, workflow constraints, validation endpoints, and comparators. Selection of a secondary track is not required.

• Track A: Posterior load-bearing Class I/II &/or large multi-surface restorations in moisture-challenged fields
• Track B: Root/cervical lesions in high-risk adult populations (e.g., high caries burden)
• Track C: Pediatric/high-caries settings with limited chair time and variable cooperation
• Track D: Field/mobile dentistry with constrained equipment, storage, and supply logistics
• Track E: Smooth surface for anterior teeth, mechanical and aesthetic considerations

What We Mean by “Restorative System”

Responsive applications must propose an integrated restorative system, not a material alone. At minimum, proposed solutions must address:

(i) the restorative material, (ii) a clinically realistic bonding/placement strategy, and (iii) a workflow/curing/setting approach appropriate to the selected track(s), with an evidence plan enabling independent replication/verification of key performance claims.

Program Description

Dental amalgam has set a long-standing benchmark for direct posterior dental restorations because it combines durability under high load, tolerance to moisture and operator variability, workflow efficiency, and low cost. As mercury-containing products are phased down globally, the dental field faces a persistent gap: no widely adopted restorative option consistently delivers this same combined performance in real-world care environments, particularly for high-stress posterior restorations and for high-caries-burden populations served in settings with time, equipment, and moisture-control constraints. Global initiatives (e.g., the Minamata Convention) are accelerating the phase-down of mercury-based products, increasing urgency for scalable alternatives.

Comparator and Clinical Relevance (required)

Applicants must identify a primary comparator appropriate to the selected track(s) (e.g., commonly used restorative system(s) in that context) and define what “success” means relative to that comparator (e.g., non-inferiority/superiority on specified endpoints). This ensures performance claims are evaluated in context and reduces ambiguity in review.

This program will accelerate the development of next-generation restorative dental systems, not materials alone – that can achieve durable, safe, affordable, and broadly deployable performance under real-world clinical constraints. Proposed solutions must address the integrated system required for clinical success, which may include the restorative material, bonding/adhesive strategy, and delivery/placement and curing/setting approach, engineered for reliable performance when ideal isolation and moisture control cannot always be assured (e.g., challenging moisture management, subgingival margins, limited patient cooperation, and time/equipment limitations).

Workflow Performance Targets (track-appropriate)

Solutions should be designed for real-world workflow constraints relevant to the selected track(s), including time-to-place, equipment dependencies, and tolerance to operator variability. Applicants should describe equipment requirements and any fallback mode for constrained settings (e.g., limited light-curing capability, limited isolation).

Solutions are encouraged to address common failure modes that limit current posterior and non-posterior (e.g., anterior and root) restoratives in moisture-challenged settings, such as fatigue and wear, marginal breakdown/microleakage, debonding, hydrolytic degradation, polymerization shrinkage/shrinkage stress (when relevant), and secondary caries risk, using system-level strategies (e.g., improved bonding in moist fields, bioactive/remineralizing or anti-biofilm functions) without compromising mechanical durability, safety (including relevant byproducts/leachables), shelf-life, manufacturability, or cost trajectory.

This program prioritizes solutions that pair scientific innovation with translational execution discipline, delivering restorative systems with credible pathways to independent validation, scalable manufacturing, and sustainable adoption in the care settings and populations most impacted by caries and constrained access to care, while supporting environmental sustainability objectives.

Non-Responsive Applications (will not be advanced)

Applications are considered non-responsive if they:

• Propose materials discovery only without an integrated bonding/placement/workflow strategy for the selected track(s);
• Do not meet the Minimum Entry Requirements (MER) (prototype readiness + minimum evidence package);
• Lack a credible plan for independent replication/verification of key claims on defined endpoints;
• Do not provide a plausible path for manufacturability and affordability consistent with the intended use setting(s).

Award Structure

The solicitation will be executed using the RADx Tech innovation funnel, a stage-gated, milestone-driven model designed to rapidly de-risk technologies and concentrate resources on solutions that can reach clinical, regulatory, and market readiness.

• Phase 0 (Application/Review): Applications are submitted online and are reviewed by an independent external expert panel using the criteria outlined in the evaluation criteria section below. Selected applicants will advance to the next stage of planning and review.
• Phase 1 (Rapid Deep Dive / Workpackage Contracting): Selected teams will participate in an interactive “Deep Dive” evaluation, which is the final due diligence stage of review prior to funding decisions. Applicants work with an assigned mentor to confirm intended use and deployment context, refine a decision-grade target product profile, and finalize a milestone work package and budget with objective go/no-go criteria across technology, clinical use context, regulatory, and market/manufacturing domains.
• Phase 2 (Independent Validation / Design-Lock Readiness): Teams will generate a decision-grade evidence package, including program-designated independent replication/verification of key performance claims on defined endpoints (analytical, usability/workflow, and durability-relevant measures), and establish formulation/process controls and quality fundamentals sufficient to support design-lock readiness.
• Phase 3 (Clinical Evidence / Regulatory Readiness / Scale-up): Teams will advance toward real-world deployment by generating clinically relevant evidence appropriate to the intended use, progressing regulatory alignment, and demonstrating manufacturing and supply-chain readiness, including stability/packaging strategy and a credible path to affordability for public and resource-constrained care systems.
  • Note: Phase 3 represents a potential later stage of the program; initial awards under this solicitation are expected to support phase 1–2 activities, with phase 3 entry contingent on program priorities and successful phase 2 outcomes.

Continued participation and payments are tied to milestone completion and independent validation outcomes.

Minimum Entry Requirements (MER)

To be responsive, applications must demonstrate readiness for a RADx funnel (prototype stage or beyond) with a minimum evidence package:

1. Prototype readiness: Reproducible formulation or formulation family; bench prototype suitable for standardized testing.
2. Baseline performance package: Basic mechanical baseline and curing/setting profile; water-related behavior (e.g., sorption/solubility proxy or chemistry-appropriate equivalent); preliminary shrinkage/shrinkage-stress proxy (if resin-based); initial biocompatibility screen plan (and/or early screen data).
3. Intended use defined: Restoration class/use case along with target clinical settings and populations (including at least one high-need setting).
4. Translational plausibility: Regulatory pathway hypothesis; manufacturing plausibility (key raw materials, scale-up risks); key cost drivers; and the value-chain plan (manufacturing, packaging/shelf-life, distribution, procurement, and adoption in target care settings).

Required MER artifacts (attachments)

To support rapid review and Deep Dive planning, applicants must provide the following as part of the submission package:

1. Prototype Definition Sheet: formulation family, mixing/curing/setting approach, packaging concept, shelf-life hypothesis
2. Baseline Performance Snapshot: key initial mechanical/handling/curing parameters relevant to the selected track
3. Intended Use & Workflow Map: setting, constraints, equipment assumptions, operator steps, time target
4. Regulatory/Standards Evidence Plan: claim → evidence mapping; standards categories to be addressed
5. Manufacturing & Cost Drivers: summary (top cost drivers, scale-up risks, raw material dependencies, path to affordability)

MER not met = non-responsive and will not advance.

Evaluation Criteria

Each application will be reviewed by an independent external expert panel. All applications must address the existing gap in restorative dental materials. Applications must provide details on how performance will be assessed, and real-world clinically significant and relevant results will be accomplished and verified. Consistent with the RADx Innovation Funnel, advancement and continued funding will depend on milestone completion and independent replication/verification of key performance claims through RADx validation resources or contracted third parties (e.g., validation center/CRO partners). Applicants must identify which tests will be developer-run versus independently replicated and which endpoints are required for advancement.

Review emphasis

Reviewers will prioritize:

1. Fit to selected track(s) & unmet need
2. Technical plausibility vs key failure modes
3. Workflow realism and usability under constraints
4. Decision-grade validation plan (including independent replication endpoints)
5. Regulatory/quality/manufacturing readiness
6. Affordability and adoption plausibility in target settings

Assessment Impact of Incomplete Criteria Coverage

Applications will be evaluated according to the review criteria described. The strength, clarity, and completeness with which applicants address these criteria will inform reviewer assessment of overall merit and readiness for advancement within the RADx innovation funnel.

Applications that do not sufficiently address one or more of the elements below may be assessed less favorably under the relevant review criteria:

• Intended Use Context and Track Selection: Clear identification of the primary use-case track and clinical deployment context, including the target care setting, patient population, and workflow constraints relevant to the proposed restorative system.
• Comparator Justification: Identification of an appropriate comparator restorative system for the selected use-case track, along with a clear definition of success criteria (for example, non-inferiority or superiority on defined analytical, durability, or workflow endpoints).
• Independent Replication / Verification Plan: Credible and well-defined strategy for independent validation of key performance claims on specified endpoints.
• Manufacturability and Affordability Plausibility: Realistic path toward scalable manufacturing, including formulation reproducibility, packaging and stability strategy, supply-chain feasibility, and cost structures compatible with the intended care settings.
• Team Capability Coverage: Demonstrated access to the expertise required to translate the proposed technology, including dental materials science, clinical workflow relevance, regulatory and quality strategy, and manufacturing or scale-up capability.

Performance requirements that should be addressed and will be considered:

1. Alignment with FDA expectations and compliance with consensus/emerging standards
2. Durability: Applicants must provide a durability evidence plan that maps to long-term performance (≥10 years in oral environment under high-stress (physical, chemical, biologic)) using accelerated aging and clinically relevant surrogate endpoints (e.g., fatigue/wear, marginal integrity, hydrolytic stability, thermocycling, and chemistry-appropriate chemical/biologic challenges). The plan must specify failure modes interrogated, thresholds, and go/no-go criteria.
3. Biocompatibility and Safety: Applicants must provide a risk-based early-stage biocompatibility and safety strategy appropriate to the formulation class, intended oral exposure, and selected use-case track(s). At a minimum, this strategy should address: (i) early predictive biocompatibility screening and/or preliminary screening data; (ii) likely extractables/leachables, degradation byproducts, and cure-/setting-related residual risk relevant to the material system; (iii) when relevant, a fit-for-purpose plan to assess particulate/wear-debris generation under track-relevant finishing, polishing, and functional wear conditions; and (iv) how safety evidence and controls will mature as formulation/process parameters are locked and the system advances toward design-lock readiness and final product compliance.
4. Usability/Workflow: Applicants must specify track-appropriate workflow targets (time-to-place, steps, equipment dependencies), and demonstrate a credible path to usability under real-world constraints, including operator variability and moisture/isolation limitations.
5. Shelf-life: Storage at room temperature and extreme conditions for low resources settings
6. Enhanced resistance to secondary caries and mechanical failure
7. Aesthetics: Translucency – cosmetically matching to natural teeth
8. Manufacturability, stability, and cost trajectory: Applicants must provide a scalable synthesis/compounding plan, preliminary QC/release concepts, packaging and stability strategy supporting shelf-life claims, and key cost drivers with a plausible path to affordability for public systems
9. Affordability Evidence Plan (required): Applicants must describe key cost drivers, expected cost trajectory at scale, packaging/shelf-life impacts, and a plausible procurement/adoption pathway for target care settings (e.g., public and resource-constrained systems).

Timeline

This solicitation will use a single posted submission deadline. The program reserves the option to extend the deadline if needed to ensure a competitive pool.

Submission Opens: Friday, March 27, 2026
Submission deadline: Friday, May 8, 2026
Applications selected for Deep Dive: Estimated June 22, 2026

Award Information

Budget should be justified based on proposed work. Initial awards for phase 2 will be no more than $250k total cost (direct and indirect). Phase 3 applications are not accepted at this time.

How to Apply

Proposals must be submitted through the Cimit online system and are due no later than 11:59pm EST on  May 8, 2026. Applicants are encouraged to thoroughly review this solicitation and the FAQs. Any questions should be sent to CimitCommunications@partners.org.

Eligibility

Eligible applicants may include for-profit companies, academic teams with commercialization partners, and consortia. Teams must include dental materials expertise, clinical workflow relevance, regulatory strategy capability, and manufacturing/scale-up competence.

Team Capability Coverage (required)

Teams must demonstrate coverage of dental materials expertise, clinical workflow relevance, regulatory/quality strategy, and manufacturing/scale-up competence, either through named team members, partners, or subcontractors.