We are committed to the highest standard of scientific evidence in the spirit of our pioneers. Our products are proven both in mechanical testing and clinical studies.
Scientific leadership since the very beginning
Our products have proven themselves in everyday clinical practice since Per-Ingvar Brånemark placed the first implant in 1965. Gösta Larsson was the first patient in a clinical study that eventually included 211 patients, 235 jaws and 1618 titanium implants.
At that time, implant treatment was neither well known nor accepted. It required scientific evidence to convince the medical community that implant treatments were safe, reliable and enduring.
Today, implant-based oral rehabilitation sets the standard of care, and our products are among the most documented in the world. There are more than 4400 independent scientific publications with data on our solutions. Our Brånemark System implant has been in clinical use for over 45 years. And our moderately rough implant surface TiUnite has been documented in over 275 publications on clinical studies, with more than 13,000 patients, 42,000 implants and up to 12 years’ follow-up.
High reporting standards
Studies on our products follow very high reporting standards. Unlike many other implant providers, we set the radiographic baseline at implant insertion rather than at prosthetic delivery a few weeks or months later. This means that we report total marginal bone level change without omitting the pronounced initial bone response to implant surgery.
Not all implants are the same
The notion that dental implants are a “mature” treatment, and that scientific evidence
When they switched from implants with TiUnite surface to implants with a chemically altered surface, their quality control study revealed a doubling of their implant failure rate, even after excluding the first 100 implants due to the learning curve. This triggered an immediate switch back to TiUnite implants, which saw failure rates return to normal levels.2
Careful material selection and thorough testing
We choose all materials very carefully, whether they’re metals, ceramics or plastics. Everything has to meet the highest standards including biocompatibility, strength and longevity. The commercially pure titanium used for our implants, for example, is much stronger than regular c.p. titanium. We increase its strength significantly through our cold-working process. All our products undergo thorough testing according to ISO standards, helping to ensure that they withstand the test of time.
Quality management according to ISO standards
Your patients want only the very best products to go into their mouths. All our products, including our NobelProcera individualized prosthetic restorations, are developed and produced according to our quality management system that complies with ISO 13485. Our processes are regularly audited by the notified body BSI and inspected by competent authorities such as the US Food and Drug Administration (FDA).
- BSI CE 00353 EC Certificate Exp. 2024-05-26
- BSI EMS 69777 ISO 14001:2015 Environmental Management System Exp. 2022-01-21
- BSI MD 81731 ISO 13485:2016 Quality Management System Exp. 2020-10-05
- BSI MDR 717177 R000 EU Quality Management System Exp. 2025-04-08
- BSI MDSAP 687164 ISO 13485:2016 Quality Management System Exp. 2021-10-05
1 Rieben AS, Jannu A, Alifanz J, Noro A, Sahlin H. Comparison of Various Study Protocols - A Literature Review [#47], in 25th Anniversary Meeting of the Academy of Osseointegration, March 4-6, 2010, Orlando, FL, USA
2 Hujoel P, Becker W, Becker B, Monitoring failure rates of commercial implant brands; substantial equivalence in question? Clin Oral Implants Res. 2013; 24(7): 725-9