[REHOVOT, Israel=WhoWired] September 21, 2011 -- Objet Ltd., the innovation leader in 3D printing for rapid prototyping and additive manufacturing, today launched a new Bio-Compatible 3D printing material (MED610™). According to Objet, the material combines bio-compatibility with high dimensional stability and clear transparency. This makes it useful for PMMA simulation and a wide range of medical and dental applications - particularly the production of highly accurate, customized surgical guides.
Dr. Stan Brodie, Specialist in Digital Implant Planning and Surgical Guides at iDent, and a user of Objet 3D printing technology, comments, "The accuracy and fine detail of Objet 3D-printed surgical guides guarantee surgeons a consistently high level of precision that's unmatched by manual processes. The new Bio-Compatible material now introduces further benefits to the process with improved transparency, making it easier to monitor underlying soft tissue during dental procedures."
Avi Cohen, Head of Medical Solutions at Objet adds, "Objet invests significantly in R&D in order to proactively meet the requirements of our customers. The advanced mechanical properties of the new Bio-Compatible material, including its clear transparency bring benefits to the entire medical and dental workflow - from surgical planning through to the procedure itself."
The new Objet Bio-Compatible material is ideal for prolonged skin contact of over 30 days and mucosal-membrane contact of up to 24 hours. It has five medical approvals according to the harmonized standard ISO 10993-1: Cytotoxicity, Genotoxicity, Delayed Type Hypersensitivity, Irritation and USP Plastic Class VI.* MED610 is also manufactured under the ISO 13485:2003 certification, which specifies that each and every batch of the material undergoes bio-compatibility conformity testing, including GC-FID before it is packaged. This ensures the highest bio-compatible standards for medical and dental application requirements.
MED610 is the second material the company has created specifically for dental and medical applications. It joins the company's original Objet VeroDent material, currently used extensively by dental labs worldwide in the digital dental process.
The Bio-Compatible material can be used on all Objet Connex and Eden 3D printers and is available for purchase immediately. Existing customers can use this material following a software upgrade.
*Biological Testing: Parts printed by Objet according to Objet MED610 Use and Maintenance Terms (DOC-08242) were evaluated for biocompatibility in accordance with standard DIN EN ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and Testing within a risk management process. This addresses cytotoxicity, genotoxicity, delayed hypersensitivity, and USP plastic Class VI which includes the test for irritation, acute systemic toxicity and implantation.
DISCLAIMER: It is the responsibility of the Customer and its respective customers and end-users to determine the biocompatibility of all the component parts and materials used in its finished products for their respective purposes, including in relation to prolonged skin contact (of more than 30 days) and short-term mucosal-membrane contact (up to 24 hours). Results may vary if different conditions apply than those existing at Objet Ltd.'s ("Objet") laboratories at testing time and those that applied for the purposes of the evaluation of biological testing specified in 2009, Biological evaluation of medical devices-Part 1: Evaluation and Testing within a risk management process. Customer acknowledges the contents of this document and that Objet parts, materials, and supplies are subject to its standard terms and conditions identified at http://www.objet.com/termsandconditions/ which are incorporated herein by reference.
Objet does not guarantee the final release and availability of materials, products and/or features referred to herein. Materials will be released subject to Objet's sole discretion. Not all released materials are currently available for all platforms / systems. Objet will update its website further as releases become available and/or compatible with specific platforms/systems.
SOURCE Objet Geometries Ltd.
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