FDA has replaced two long-standing dental-device 510(k) guidances
FDA announced the availability of two final guidances on September 2, 2026:
- Dental Composite Resin Devices–Premarket Notification (510(k)) Submissions; and
- Dental Curing Lights–Premarket Notification (510(k)) Submissions.
The composite-resin guidance supersedes the October 26, 2005 guidance, while the curing-light guidance supersedes the March 27, 2006 guidance.
FDA states that the updated recommendations are intended to promote consistency and facilitate efficient review of these submissions.
Both guidances focus on device description, performance testing, and labeling
Dental composite resin devices are intended to fill and restore defects or carious lesions in teeth and may be supplied as self-cured two-part systems or photoinitiated one-part systems.
The final guidance provides recommendations on device description, non-clinical performance testing, clinical performance testing, and labeling to support premarket submissions.
Dental curing lights emit non-ionizing optical radiation to photopolymerize dental restorative resins. The final curing-light guidance similarly addresses device description, performance testing, and labeling for 510(k) submissions.
FDA made specific changes from the 2024 drafts
FDA’s Federal Register notice identifies several changes made after review of comments on the 2024 draft guidances.
Composite resin: shelf-life testing was clarified
For dental composite resin devices, FDA clarified appropriate performance testing used to evaluate shelf life and made additional technical edits.
Manufacturers with existing stability or shelf-life test plans should therefore compare those protocols against the final guidance rather than assuming the 2024 draft remains unchanged.
Curing lights: radiant power is measured at the tip
For dental curing lights, FDA revised the guidance to specify radiant power output at the tip rather than at a point 2 mm from the tip.
FDA also removed resin depth-of-cure measurements and made other technical edits and clarifications.
These changes are particularly relevant for teams that already developed verification plans based on the draft guidance.
The guidances are nonbinding but represent FDA’s current review thinking
The final guidances were issued under FDA’s good guidance practices regulation.
They do not establish legally enforceable rights or responsibilities, and an alternative approach may be used if it satisfies applicable statutory and regulatory requirements.
For 510(k) preparation, however, the documents represent FDA’s current recommendations and are likely to shape reviewer expectations around the organization and technical support of the submission.
What companies can check
- Identify active U.S. dental composite resin and curing-light projects still referencing the 2005 or 2006 guidances.
- Compare testing already performed under the 2024 draft guidances with the final recommendations.
- Review shelf-life performance testing for composite resin devices against the clarified final guidance.
- Confirm that curing-light radiant power output testing is performed at the tip where the final guidance specifies that location.
- Reassess whether resin depth-of-cure testing remains necessary for another purpose rather than treating it as a current FDA final-guidance expectation.
- Update device description, labeling, test reports, and standards references in the 510(k) dossier where needed.
For dental-device manufacturers, this is a practical submission update rather than a new legal regime. The main task is to align ongoing 510(k) work with the final 2026 recommendations and remove assumptions carried over from the superseded or draft documents.
Sources
- Primary official sourceDental Composite Resin Devices and Dental Curing Lights--Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceDental Composite Resin Devices - Premarket Notification (510(k)) Submissions (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceDental Curing Lights - Premarket Notification (510(k)) Submissions (opens in a new tab)U.S. Food and Drug Administration