FDA 510(k)

3D Printing News Briefs, November 18, 2023: Depowdering, Jewelry Patterns, & More

We’re kicking off 3D Printing News Briefs with a little business today, as Horizon Microtechnologies invested in a micro AM platform from Boston Micro Fabrication, and Rivelin Robotics announced a…

3D Printing News Unpeeled: 3D Systems Base Resin, ArcelorMittal Enters Powder Market and the NIOSH

The US´s National Institute for Occupational Safety and Health (NIOSH) has released a set of guidelines for using 3D printing called, ¨Approaches to safe 3D printing: a guide for makerspace…

FDA Clears 3D Systems Material for 3D Printing Denture Bases

3D Systems (NYSE: DDD) has announced a significant addition to its dental 3D printing offerings with the FDA 510(k) clearance of its NextDent Base material. The news represents an important…

Carbon & Desktop Health Partner for FDA-approved Dental 3D Printing

Taking a significant stride in digital dentistry, Desktop Health and Carbon have inked a new partnership. By integrating the groundbreaking Flexcera family of resins by Desktop Health with Carbon’s digital manufacturing…

LuxCreo Gets FDA Class II 510(k) Clearance for Direct 3D Printed Dental Aligners

Dental aligners made through thermoforming based on 3D printed inserts are one of the biggest additive manufacturing (AM) applications in the world. Pioneered by Align and now used by Smile…

3D Printing News Unpeeled: No You Can’t 3D Print a Ferrari and Clear Aligners Clearance

LuxCreo got FDA Class II 510(k) clearance for directly 3D printed clear dental aligners. They hope to do same day aligners in perhaps two hours. They say that the direct aligners…

3D Printing News Briefs, March 15, 2023: Software, Carbon Fiber Bikes, & More

In today’s 3D Printing News Briefs, Velo3D has released the latest version of its Flow software, and Horizon is opening up more micro additive manufacturing applications with a coating that…

Desktop Health’s SmileGuard Dental 3D Printing Resin Receives Full FDA 510(k) Clearance

Desktop Health, a business within the Desktop Metal umbrella, has recently announced that its SmileGuard light-curable biocompatible resin has received full U.S. Food and Drug Administration (FDA) 510(k) clearance. The…

FDA 510(k) Clearance for 3D LifePrints

3D LifePrints‘ Cranio-Maxillofacial surgical planning product, EmbedMed, has received FDA 510(k) clearance. An ISO 13485-certified cloud tool, EmbedMed gives clinicians access to the entire workflow needed to convert DICOM or…

3D Printed Pelvic Implants from Onkos Surgical Earn FDA Clearance

The medical field is, rightly so, a highly regulated one, and you can’t really get momentum for a product until it’s received clearance from the U.S. Food and Drug Administration…

FDA Clears Ricoh Healthcare Solution to 3D Print Personalized Anatomical Models

Japan-based multinational Ricoh revealed that its RICOH 3D for Healthcare solution, which integrates with IBM iConnect Access from IBM Watson Health to fabricate 3D printed anatomic models, has received 510(k)…

3D Printed Patient-Specific Cancer Treatment Bolus Added to 3D Systems Portfolio

As part of their treatment regime, about 50% of cancer patients will undergo radiotherapy, which kills the cancer cells using a focused beam outside of the body or placing radioactive…

Desktop Health Unveils New 3D Printer Series to Strengthen Dental Portfolio

Desktop Health, the recently launched healthcare business within Desktop Metal, Inc. (NYSE: DM), works to create 3D printing solutions for multiple areas of personalized medicine. This includes a focus on…

Point of Care Medical 3D Printing Enabled by New RIZE Partnership

After the successful implementation of additive manufacturing (AM) in aerospace, medical 3D printing has been leading the charge for adoption for a number of applications. Among the most accessible is…

FDA Approves Onkos Surgical’s 3D Printed Collar Implants

Specialized MedTech company Onkos Surgical has received FDA 510(k) clearance to market its modular collars used for musculoskeletal oncology and complex orthopedic limb salvage surgery. Made specific to each patient…