Dentsply Sirona Regenerative Solutions

We are the ones that can make your work – flow

 

Science and documentation, innovation and education is at the core of what we do. From this, we develop solutions that save time and effort, while helping you achieve the best possible results for your patients.

Our commitment to you—we will make your work – flow.

That is why we offer dental solutions and products that will help boost your efficiency, make it easier to manage time and increase patient satisfaction—every day. Just tell us about your needs, challenges, and way of working. Based on that, we suggest solutions that save time and effort, while helping you achieve the best possible results for your patients. Our offer includes OSSIX^® and Symbios^® brands which poses several bone grafting materials, dental membranes, and our full line of instrumentation and educational programs. Always backed by sound science. Always designed to make your work – flow.

Learn more: Bone regeneration in implants | Dentsply Sirona USA

Core Technology, Quality & Safety

Following its acquisition by Dentsply Sirona, Datum Dental has integrated its extensive intellectual property rights and expertise into a global framework. This includes the advanced technology, trademarks, and comprehensive manufacturing and R&D data of Colbar Life Science, originally acquired from Johnson & Johnson (J&J), along with all related regulatory documentation. Dentsply Sirona continues to drive the advancement of GLYMATRIX^® core technology, refining existing products and expanding the portfolio to address the evolving needs of dental professionals worldwide.

Dentsply Sirona Regenerative Solutions remains steadfast in upholding the highest quality and safety standards for its GLYMATRIX^® core technology and OSSIX^® products. Our unwavering commitment to excellence is evident in the rigorous certifications and compliance measures we maintain, ensuring our products consistently meet and surpass industry standards. Our headquarters, featuring state-of-the-art clean rooms within a 43,056-square-meter GMP facility, adhere to stringent compliance certifications, including:

• ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
• ISO 22442: Medical devices utilizing animal tissues and their derivatives
• CE Mark: Under the EU Medical Devices Directive
• U.S. FDA 21 CFR 820: Current Good Manufacturing Practices (CGMPs) – Quality System Regulation
• Canadian Medical Devices Regulations (CMDR)

All GLYMATRIX^® based OSSIX^® products are meticulously manufactured in-house within our certified cleanroom facilities, ensuring that from source material to final product, each step meets the highest standards of safety and biocompatibility.