🇺🇸 Biodentine in United States

Biodentine (Biodentine) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Biodentine in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Biodentine approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Biodentine in United States?

Universidad de los Andes, Chile is the originator. The local marketing authorisation holder may differ — check the official source linked above.