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Artificial Dentures: The Revolution of 3D Printing – Printed via Stereolithography (SLA), the resin dentures can be made directly from 3D models, instead of through Casts

Artificial Dentures: The Revolution of 3D Printing – Printed via Stereolithography (SLA), the resin dentures can be made directly from 3D models, instead of through Casts

 

Curators: Gerard Loiseau, ESQ and Aviva Lev-Ari, PhD, RN

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K143033

Device Name Dentca Denture Base Indications for Use (Describe)

Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.

SOURCE

http://www.accessdata.fda.gov/cdrh_docs/pdf14/K143033.pdf

For the First Time in Dental History, DENTCA, Inc. Receives FDA Clearance for the First 3D Printable Denture Base Material; Able to Be Worn Inside the Mouth.

The FDA has officially approved last week a 510(k) for the use of DENTCA’s new 3D printable material as a denture base that will revolutionize the denture world; making the denture production process quicker, more accurate and more predictable.

The new developments will create incredible possibilities for patients, as doctors will soon be able to 3D print final dentures at their office, allowing the manufacture process to be done in one day everywhere in the world.

DENTCA, Inc. continues to revolutionize the denture world.

The FDA last week officially approved a 510(k) for the use of DENTCA’s new 3D printable material as a denture base that will revolutionize the denture making world.
Dr. Jason Lee is the proud creator of this technology and has shared excitingly his opinion:
“After several years in development DENTCA’s new 3D printable Denture Base is finally cleared for use. We are very excited to begin applying this technology to continue revolutionizing the denture world. The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates; which will eventually replace traditional heat-cured and auto polymerizing conventional denture making methods. By improving the manufacture process with the help of precise 3D printers, we will be making the denture production process quicker, more accurate and more predictable. DENTCA already revolutionized the fit of dentures by directly scanning the impressions instead of the need to pour a stone; now it will further increase it by removing the need for a flask in the future market, thus significantly reducing distortion.”

Fabrication of dental prosthetics with DENTCA Denture Base utilizes a computer-aided design and manufacturing (CAD/CAM) software system, specialized tray impression systems, and a digital denture file database the system automates the denture making process almost to perfection; and now by also incorporating an optical impression system, a stereolithographic additive printer, and curing light equipment; it finally closes a cycle for success, giving the doctor a completely evolved denture manufacture process.

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.

When inquired about DENTCA’s recent breakthrough, the CEO of the company Mr. Sun Kwon shared the following: “This clearance completely revolutionizes the denture manufacture process, which has barely changed in over 100 years. The new developments will create incredible possibilities for patients, as doctors will soon be able to 3D print final dentures at their office, allowing the manufacture process to be done in one day everywhere in the world. Stay tuned for new and exciting updates.”

It is indeed exciting times for prosthodontics today.

SOURCE

http://www.prweb.com/releases/2015/08/prweb12893381.htm

 

Aug 10, 2015 | By Lilian

The FDA granted 16 dental devices 510(k) clearance in July, one of them is Dentca Denture Base fromDentca. At the end of last month, the FDA officially approved a 510(k) for the use of DENTCA’s new 3D printable material as a denture base.

According to a press release, the material has passed all 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.

Fabrication of dental prosthetics with DENTCA Denture Base utilizes a CAD/CAM software system, specialized tray impression systems, and a digital denture file database. Now by also incorporating an optical impression system, a stereolithographic additive printer, and curing light equipment, it gives the doctor a completely evolved denture manufacture process.

Dr. Jason Lee, the proud creator of this technology shared excitingly his opinion:

“After several years in development DENTCA’s new 3D printable Denture Base is finally cleared for use. We are very excited to begin applying this technology to continue revolutionizing the denture world. The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates; which will eventually replace traditional heat-cured and auto polymerizing conventional denture making methods. By improving the manufacture process with the help of precise 3D printers, we will be making the denture production process quicker, more accurate and more predictable. DENTCA already revolutionized the fit of dentures by directly scanning the impressions instead of the need to pour a stone; now it will further increase it by removing the need for a flask in the future market, thus significantly reducing distortion.”

SOURCE

http://www.3ders.org/articles/20150810-dentca-receives-fda-clearance-for-the-first-3d-printable-denture-base-material.html

 

Orthodontic company DENTCA has received 510(k) approval of a material that will be used to 3D print the bases of dentures, allowing DENTCA to create perfectly tailored dentures and baseplates from patient scans.  Printed via stereolithography (SLA), the resin dentures can be made directly from 3D models, instead of through casts, allowing the company to automate the manufacturing process.

VIEW VIDEO

http://3dprintingindustry.com/2015/08/10/dentures-get-3d-printed-boost-with-dentcas-fda-approval/

Dr. Jason Lee, inventor of the process, explains, “After several years in development DENTCA’s new 3D printable Denture Base is finally cleared for use. We are very excited to begin applying this technology to continue revolutionizing the denture world. The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates; which will eventually replace traditional heat-cured and auto polymerizing conventional denture making methods.” He continues, “By improving the manufacture process with the help of precise 3D printers, we will be making the denture production process quicker, more accurate and more predictable. DENTCA already revolutionized the fit of dentures by directly scanning the impressions instead of the need to pour a stone; now it will further increase it by removing the need for a flask in the future market, thus significantly reducing distortion.”

dentca 3D printed denture bases get FDA approval

DENTCA’s Denture Base involves a unique system that combines the company’s denture file database with an optical impression system, the SLA printer, and the necessary light curing to create a complete, closed cycle for producing their dentures.  Now that the material involved has received FDA approval, deemed suitable for contact with human tissue for longer than 30 days, the product can be brought to market.  DENTCA envisions their systems installed in doctor’s offices, with CEO Sun Kwon saying, “This clearance completely revolutionizes the denture manufacture process, which has barely changed in over 100 years. The new developments will create incredible possibilities for patients, as doctors will soon be able to 3D print final dentures at their office, allowing the manufacture process to be done in one day everywhere in the world. Stay tuned for new and exciting updates.”

It’s exciting to see an increasing range of technologies and materials approved by the FDA so that 3D printing can more quickly improve the lives of those with access to it.

SOURCE

http://3dprintingindustry.com/2015/08/10/dentures-get-3d-printed-boost-with-dentcas-fda-approval/

 

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