Datum Dental Ltd provides innovative regenerative solutions to support and enhance the future of implantology and oral care. The company markets its products for dental professionals through its extensive global network of over 20 partners in more than 35 countries worldwide.
Advancing collagen technology, to develop safe and effective medical devices, that improve human health.
Datum Dental, affiliated with Datum Biotech, uses its patented GLYMATRIX® core technology, a sugar cross-linking collagen biomaterial, for guided bone regeneration (GBR) and guided tissue regeneration (GTR) — clinically proven in over 100 scientific publications. Powered by GLYMATRIX, the OSSIX® product family has enabled clinicians in hundreds of thousands of procedures spanning almost two decades to safely provide predictable, long-term results to their patients.
The OSSIX regenerative solutions portfolio includes legacy OSSIX® Plus ossifying collagen barrier membrane, OSSIX™ Bone ossifying mineralized collagen sponge, and OSSIX® Volumax ossifying, volumizing collagen scaffold. Datum Dental’s R&D pipeline continues to develop new products for GBR and GTR that simplify procedures and overcome major deficiencies in existing biomaterials through safe and transformational solutions.
Everything we do is designed to give nature is best chance.
Datum Dental In Numbers
Over 100 Scientific Publications
Hundreds of Thousands of Procedures
Thousands of Clinicians Over 30 Countries
Trusted for safety, efficacy and predictability, clinicians worldwide turn to the OSSIX brand for their GBR & GTR needs
Quality & Safety
Datum has acquired all intellectual property rights and knowhow, including: technology, patents, trademarks, manufacturing and R&D data of Colbar Life Science from Johnson & Johnson (J&J), including related regulatory files. Furthermore, Datum has continued to develop its GLYMATRIX core technology by contributing new qualities and attributes to the current products, as well as expanding the Company’s product portfolio.
Datum Dental adheres to stringent quality and safety standards for its GLYMATRIX core technology and OSSIX products (refer to the IFU Library for full information on indications and contraindications).The company’s headquarters include clean rooms in its 750 square meter GMP facility with compliance certifications for
- International Organization for Standardization (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. Food & Drug Administration (FDA) Title 21CFR of the Code of Federal Regulations Part 820 (21 CFR 820) current good manufacturing practices (CGMP’s), Quality System Regulation
- Canadian Medical Devices Regulations (CMDR)
All GLYMATRIX-based OSSIX products are manufactured in-house in Datum Dental’s cleanroom—from source material to safe, highly biocompatible final products.