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Wednesday, August 12, 2015

Dentures from a 3D Printer

Dentures Get 3D Printed Boost with DENTCA’s FDA Approval

Michael Molitch-Hou | August 10, 2015


The medical space is set to be the first major industry to be galvanized by 3D printing technology, uniting many of 3D printing’s strengths in a field that has immediate, life-enhancing effects.  While operating rooms the world over are now implementing the technology to perform vital surgeries, taking advantage of patient-tailored implants and patient-specific surgical models, the FDA is now catching on to 3D printing’s increasingly important role in medicine.  The Food and Drug Administration has now approved 3D printed facial, cranial, and multiple spinal implants, as well as the first 3D printed pharmaceutical, and, today, it has given clearance to a material for 3D printing parts of dentures.


Source: http://www.3ders.org/articles/20150810-dentca-receives-fda-clearance-for-the-first-3d-printable-denture-base-material.html  According to a press release, the material has passed al recent biocompatibility tests placed in evaluation for the DENTCA Denture Base in accordance with the FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1, as recognized by FDA. The battery of testing included tests for Genotoxicity, Cytotoxicity, Sensitization, Irritation, Acute Toxicity & Material Characterization which the printable material passed with flying colors. Declaring the 3D printable material for considered tissue contacting for a period longer than 30 days (a removable prosthesis). DENTCA Denture Base was tested for conformity with the industry consensus standard ISO 20795-1.

<more at http://3dprintingindustry.com/2015/08/10/dentures-get-3d-printed-boost-with-dentcas-fda-approval/; related links: http://www.3ders.org/articles/20150810-dentca-receives-fda-clearance-for-the-first-3d-printable-denture-base-material.html (DENTCA receives FDA Clearance for the First 3D printable denture base material; able to be worn inside the mouth. August 10, 2105) and http://www.dentca.com/why.asp (+Video) (3D Denture Revolution: The Art and Science of Making Perfect Dentures Every Time)>

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