Development status

ALGINAGRAFT™ is at the development stage. It has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority, no clinical study has begun, and no bench, preclinical or clinical data for the composition have been published. It is not available for sale or clinical use.

Technology under development. Not cleared or approved by FDA. Not available for sale or clinical use. Design objectives described on this page have not been demonstrated in bench, preclinical or clinical testing.

Where the work stands

Regulatory. No premarket submission has been announced. The composition is not cleared for any indication.

Data. Nothing has been published for ALGINAGRAFT™ itself. The evidence page reports what the literature says about alginate hydrogels and about graft carriers in general, including a result that cuts against the concept.

Intellectual property. A granted US and European patent family covers a pre-portioned, single-dose bone graft composition in a dissolvable carrier. The alginate composition is the subject of a pending US application. Details and full titles are on the patents page.

What comes next. Bench characterization of the composition — handling, hydration behaviour, stability of the matrix — followed by preclinical evaluation and, if warranted, a premarket submission. No dates are promised. This page is updated when a step is completed, and each update carries its date.

The regulatory pathway for a dental bone grafting material in the United States

Dental bone grafting materials are regulated under 21 CFR 872.3930. Three product codes cover Class II materials: LYC for synthetic materials, NPM for materials of animal origin, and NUN for materials of human origin. Class II devices reach the market through a 510(k) premarket notification that demonstrates substantial equivalence to a legally marketed predicate. Which code a future ALGINAGRAFT™ configuration would fall under depends on the particulate graft material selected, and is determined by FDA, not by the developer.

Adding a growth factor or another biologic component moves a graft into Class III (product code NPZ) and the premarket approval pathway. In the public record, three dental bone graft products with a biologic component have gone through that pathway: INFUSE Bone Graft, GEM 21S, and PEPGEN P-15. This is why the current design contains no such component, and why research into additional agents is kept separate from the composition.

In August 2025, FDA published final guidance on animal studies for dental bone grafting material 510(k) submissions (docket FDA-2024-D-1242). It defines the expectations for preclinical work in this category and is the framework the development plan follows.

What the registry says about the category

Counts retrieved from openFDA on September 10, 2026. Across the full record, the three dental graft codes hold 286 cleared 510(k)s (LYC 231, NPM 40, NUN 15). Clearances per five-year period fell from 67 in 2006–2010 to 19 in 2021–2026. No new device has been cleared under NUN since January 10, 2014, while 151 NUN listings remain in active distribution on earlier clearances. Among clearances issued since 2016, 43% went to US applicants; the rest to companies in Korea, Switzerland, Taiwan, Finland and China. The full analysis, with queries, is in the Journal.

Change log

  • 2026-09-11 — Page created. Status: development. No data published, no clinical study, no regulatory filing announced.

Sources

  1. 21 CFR 872.3930 — Bone grafting material (Dental Devices)
  2. FDA, Animal Studies for Dental Bone Grafting Material Devices — Premarket Notification (510(k)) Submissions, final guidance, August 2025
  3. openFDA Device Classification — product code LYC
  4. openFDA 510(k) — product codes LYC, NPM, NUN (query used for counts)
  5. FDA Premarket Approval database — P050053 (INFUSE Bone Graft)