https://3dheals.com/biocompatible-materials-in-3d-printed-products/ Discover 3D Bioprinting and Healthcare Innovations Mon, 21 Feb 2022 19:12:43 +0000 hourly 1 https://wordpress.org/?v=7.0 https://3dheals.com/biocompatible-materials-in-3d-printed-products/#comment-189 Thu, 09 Nov 2017 18:32:17 +0000 https://3dheals.com/?p=1456#comment-189 For clarity, a Class IIa material is a designation under EU standards. That does not confer any regulatory stature to devices sold in the US. Under FDA regulations, a dental splint is a Class II medical device (different that a Class IIA device under EU standards) and requires a 510(k) for legal marketing in the US. To the best of my knowledge, no company has a materials cleared under 510(k) regulations for a 3D printed dental split.

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