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FDA Raises the Bar on 510(k)s for Dental Resin Devices, Ultraviolet Curing Lights​Regulatory Affairs

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 The FDA offers new recommendations for testing and information to include in 510(k) submissions for dental resin devices and the ultraviolet curing lights used to set the resins, in two new draft guidances released Friday.

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July 12, 2024 ·

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