Next-Generation Restorative Dental Systems for Durable, Safe, Affordable Care Under Real-World Clinical Constraints
General
Is this an NIH grant application?
No. Solicitation, review, and oversight of awards is coordinated by the RADx Coordination Center. Awards comply with NIH policies, but this application does not count toward the NIH application limit.
Is this a standard NIH R01?
No. This program operates through the RADx® Tech innovation funnel. The final solicitation specifies the funding instrument used by NIH. Deep Dive due diligence precedes award finalization.
What is the “Deep Dive”?
A Deep Dive is an interactive diligence phase used to:
- Confirm Primary Track and Intended Use
- Refine a decision-grade Target Product Profile (TPP)
- Finalize milestone-based work packages with objective go/no-go criteria
Where do I submit?
Submit via the Cimit online portal listed in the solicitation by the published deadline, May 8, 2026. Applications emailed to staff will not be accepted.
Can I submit a video?
Yes. You may submit an optional ≤3-minute video link. It must complement (not replace) the 3-page supporting PDF(s).
May I include references?
You may include as many references as you would like.
Should I submit copies of relevant publications?
Please do not submit copies of relevant publications. Standard citation of publications is acceptable.
Will I get feedback?
Limited feedback will be given if your application is not selected. Detailed feedback will be given during Deep Dive if your application advances.
Can I do animal or human subjects research in the initial phase?
Yes. If design/technical work is complete and ready for animal or first-in-human evaluation.
Who do I contact if my question isn’t addressed in the FAQ?
Please send an email to CimitCommunications@partners.org.
Application Requirements
Must I select a track?
Yes. One primary track is required. One secondary track is optional (do not dilute evidence).
What must Intended Use include?
- Restoration class (standard clinical language)
- Setting (e.g., FQHC, Medicaid clinic, rural, mobile)
- Target population
- Real-world constraints (moisture, time, equipment, cooperation)
Track selection anchors:
- Comparator
- Workflow targets
- Endpoints
- Validation plan
- Go/no-go thresholds
If your track is vague, your application will be vague.
What Is an “Integrated Restorative System”?
This program funds systems, not materials.
Your solution must address:
- Restorative material
- Bonding/placement strategy
- Workflow/curing/setting approach
All three must work together under your selected track constraints.
What are the Minimum Entry Requirements (MER)?
To be responsive, you must demonstrate:
A. Prototype-Stage Readiness
- Reproducible formulation (or formulation family)
- Bench prototype suitable for standardized testing
B. Baseline Performance Snapshot
- Track-relevant mechanical proxy
- Curing/setting profile
- Water interaction proxy
- Shrinkage proxy (if resin-based)
- Early biocompatibility screen plan or preliminary data
C. Translational Plausibility
- Regulatory pathway hypothesis
- Manufacturing plausibility
- Top cost drivers
- Adoption pathway
What is required for evidence & independent replication?
You should present no more than 3-5 key claims. Each claim must map to:
- Endpoint
- Comparator
- Method concept
- Current evidence status
- Plan for independent replication (if advanced)
Independent replication requires:
- Samples
- High-level SOPs
- Defined acceptance ranges
- Reproducibility risk controls
How is workflow realism defined?
We do not mandate:
- Rubber dam
- ≤15-minute procedure
- ≤40-second cure
We require:
- Track-appropriate workflow targets
- Equipment dependencies
- Moisture tolerance logic
- Optional fallback mode for constrained environments
“Operator forgiveness” must be defined, not implied.
What is expected for safety/biocompatibility at the application stage?
Because this program targets mercury-free restorative systems intended to perform under real-world constraints, competitive applications include a risk-based safety plan tied to your Track, system chemistry, key claims, and process/workflow controls. At submission, reviewers expect:
- A risk-based biocompatibility screening plan (and any preliminary screening data if available)
- A clear extractables/leachables (E/L) and degradation/byproduct risk logic appropriate to your formulation class and cure/setting conditions
- Mitigation logic (how formulation, cure completeness/setting controls, stabilization, packaging, and workflow reduce risk)
- A plan for how safety evidence matures as design-lock approaches (including what would be appropriate for independent verification if advanced)
Do we need full ISO 10993 testing in the application?
No. Full ISO 10993 test matrices are not required at application stage. Provide a credible, risk-based strategy aligned to oral contact and your material system and describe how your safety plan will become more definitive as formulation/process controls are locked.
How should applicants address particulate/wear debris (micro-/nano-particulates) risk?
If your system contains polymeric components or is expected to generate debris (especially in posterior/high-wear tracks), briefly describe a fit-for-purpose plan to:
- Characterize particle generation during finishing/polishing and under wear/fatigue proxies
- Report particle size range/distribution and composition (fit-for-purpose level)
- Address exposure routes (e.g., patient oral ingestion; operator exposure during finishing)
- Define mitigation steps (formulation choices, cure completeness, polishing protocol, packaging/storage controls) and what would trigger redesign/controls
Do special populations matter for safety planning?
Yes. This program prioritizes high-need/low-resource settings and populations. Your safety plan should note, at a logic level, any relevant considerations for pediatrics/high-caries settings, pregnancy, hypersensitivity, and other contexts where technique variability or constrained settings could increase incomplete cure, degradation, or exposure.
What should be included for manufacturing & affordability?
You must include:
- Scale-up risks
- Raw material dependencies
- Preliminary QC logic
- Top cost drivers
- Directional cost trajectory
- Plausible procurement/adoption pathway
Affordability is required as it is a core program objective.
Who should I list as team members and collaborators?
List only individuals who are considered key personnel or significant contributors to the work that will be performed, and who have already agreed to their role. For all proposals, the review committee requires that investigators collaborate closely with clinicians and product development experts in the development of the proposal and the conduct of the work. The input of these collaborators must be clearly reflected throughout the application.
Your team must cover:
- Materials/chemistry expertise
- Clinical workflow insight
- Regulatory/quality strategy
- Manufacturing/scale-up
- Commercialization/adoption
Do not include honorary collaborators.
What supporting PDFs must be included?
- Use-Case Snapshot
- Comparator and Success Table
- Claims to Evidence Map Table
- Link key performance claims to measurable endpoints.
- Baseline Performance Table
- Workflow Map and Fallback Mode
- Manufacturing and Cost Drivers Summary
What are the most common reasons applications may fail?
Applications are deemed non-responsive when they:
- Propose a material only (no integrated bonding/placement/workflow strategy)
- Do not meet Minimum Entry Requirements (MER)
- Lack a comparator and defined success criteria
- Present marketing claims without measurable endpoints
- Provide no manufacturability or affordability logic
Technical Evidence Expectations
The seven areas below define what reviewers expect to see in a competitive submission.
Evidence architecture (required structure)
Each key claim must include:
Component | Required |
Claim | Concise, testable statement |
Endpoint | Measurable variable |
Comparator | Named, justified |
Directionality | Non-inferiority or superiority |
Threshold | Defined target (if feasible) |
Current Status | Data available vs planned |
Replication Plan | Developer vs independent |
Baseline performance snapshot (minimum)
Provide initial measured values (best available):
- Mechanical proxy relevant to dominant failure mode
- Curing/setting profile (timing and sensitivity)
- Water interaction proxy
- Shrinkage proxy (if resin-based)
- Early durability stress proxy (if available)
Numeric values are preferred over “meets standard” statements.
Independent replication readiness
You must be able to provide (if advanced):
- Physical samples
- Controlled formulation definition
- Process parameter ranges
- Acceptance criteria
- Identified variability risks
Replication must be feasible without proprietary disclosure of unnecessary trade secrets.
Durability under track constraints
Durability plans must interrogate:
- Wear/fatigue
- Marginal integrity surrogate
- Debonding risk
- Hydrolytic degradation
- Shrinkage stress (if relevant)
Accelerated aging should reflect your track realities.
Safety & leachables logic
At this stage, reviewers expect a risk-based safety strategy that is track-anchored, chemistry-aware, and testable, without requiring a full regulatory dossier at application. Provide safety logic that is explicitly linked to: track/intended use, system components (material and bonding/placement and workflow/curing/setting), claims to evidence map, and process controls (manufacturing, cure/setting, storage/packaging).
At a minimum, include:
- Risk-based biocompatibility screening plan and any preliminary screening data if available
- Identification of likely E/L and degradation/byproduct classes relevant to formulation class and cure/setting conditions
- Stabilization/mitigation logic (how design,process and workflow reduce risk)
- Plan to evolve safety testing as design-lock approaches, including which safety endpoints would be appropriate for independent verification if advanced
- Full ISO testing is not required at application stage
Particulate / wear debris (micro-/nano-particulates) – required when relevant
For posterior/high-wear tracks and/or polymer-containing systems, applicants should address wear-debris as a considered hazard class and propose a fit-for-purpose plan to:
- Evaluate particle generation during finishing/polishing and functional wear proxies
- Report particle size range/distribution and composition (fit-for-purpose)
- Identify exposure routes (patient ingestion; occupational exposure during finishing)
- Specify mitigation options (formulation/process/workflow controls, cure completeness, polishing protocol, packaging) and decision triggers
Special populations and additive-heavy systems (when applicable)
If proposing antimicrobial/bioactive/additive-heavy systems, include additive-specific risk logic (e.g., plausible byproducts/degradation products; release-related considerations) and how functionality will be demonstrated without increasing toxicity risk, consistent with the selected track and evidence package.
Manufacturing & cost discipline
You must identify:
- Critical process controls
- Scale-up bottlenecks
- Raw material dependency risks
- Top 3–5 cost drivers
- Directional cost-at-scale logic
- Packaging/shelf-life cost impact
Go / No-Go Milestone Logic (Phase 2)
Your phase 2 plan must include clear language that:
- Ties milestones directly to endpoints
- Includes advancement thresholds
- Separates screening experiments from decision-grade validation
- Shows how failure will trigger pivot or termination
Vague milestone language significantly lowers competitiveness.
IP
Who retains the rights to any intellectual property generated by a proposal?
Management of intellectual property will be determined by the proposal applicant’s institutional policies.
Should I disclose any unprotected proprietary information in the submission?
Protecting proprietary information is the responsibility of the applicant and the applicant institution. Consistent with NIH policy, applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, identify the pages in the application that contain this information by marking those paragraphs or lines with an asterisk (*) at the beginning of the paragraph. See more detail for the full proposal in the section below. NIH Guidance: 2.3.11 Availability and Confidentiality of Information
Budget & Reporting
Are there salary limitations for these awards?
Yes. The current NIH guidance sets the cap at $225,700.
Are there any budget restrictions or limitations?
Budgets are restricted to $250k total cost (direct and indirect). Indirect costs will be provided at your institution’s federally negotiated rate. If your institution does not have a federally negotiated rate, indirect costs may be provided up to 15%. Applicant institutions may choose to waive their indirect costs. Capital equipment must be well justified to the purpose and exclusive need of the project. Facility alterations and renovations will not be supported.
What are my reporting responsibilities if I receive an award?
An annual report will be required in accordance with the terms and conditions of the award. Quarterly reports will be required to facilitate progress. Please include reporting and milestone tracking in your budget.
Deadline
May 8, 2026
Timeline
Submission Opens: March 27, 2026
Submission deadline: May 8, 2026
Applications selected for Deep Dive: Estimated June 22, 2026