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Product safetyFDAUnited StatesImports

Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability

2 September 2026

In plain English

FDA issued two final guidances giving recommendations on device description, performance testing, and labeling for 510(k) submissions covering dental composite resin devices and dental curing lights.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
2 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions" and "Dental Curing Lights--Premarket Notification (510(k)) Submissions." These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. These guidances supersede the guida
The full text is at the source

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