Gothenburg, Sweden, 9 September 2026 – Osstell, a W&H company and the global leader in implant stability measurement, announces that it has received FDA 510(k) clearance for its reusable SmartPeg and can now offer the product to customers in the United States.
The reusable SmartPeg was introduced earlier this year as an extension of Osstell’s established SmartPeg portfolio. The FDA clearance now enables clinicians in the United States to choose between sterile single-use and reusable SmartPegs while continuing to benefit from the proven accuracy of the Osstell ISQ method. The reusable SmartPeg complements the existing portfolio and delivers identical ISQ measurements using the same validated aluminium design as the original SmartPeg.
“We are pleased to make the reusable SmartPeg available to dental professionals in the United States,” says Malin Gustavsson, CEO of Osstell. “This important regulatory milestone allows us to offer greater flexibility to clinicians while maintaining the scientific integrity and measurement accuracy that Osstell is known for.”
Designed for up to 20 reprocessing cycles, the reusable SmartPeg offers a cost-efficient alternative for implant stability measurement. It features a protective surface coating for enhanced durability, laser-marked identification for traceability, and a black magnet for clear visual differentiation from the sterile single-use version.
The reusable SmartPeg is compatible with the complete Osstell product range, including Osstell Beacon, Osstell Classic and IDx systems. Clinicians can select the SmartPeg option that best fits their clinical workflow and preferences, while relying on the same validated Resonance Frequency Analysis (RFA) technology and ISQ scale.
About Osstell
Osstell is the global leader in implant stability measurement. Since the company’s founding in 1999, over thousands of scientific studies have been published confirming the clinical value of Osstell’s proprietary Resonance Frequency Analysis (RFA) technology and the Osstell ISQ scale (Implant Stability Quotient). In 2018, Osstell became a part of the W&H Group, a global leader in the development and manufacture of medical technology products with over 1,300 employees. Osstell is headquartered in Gothenburg, Sweden, the birthplace of dental implants. Our product solution is available in more than 70 countries, through our own presence and a vast network of distributors worldwide.
We empower dental professionals by providing objective implant stability measurements to provide each patient with optimal time to teeth and improve patient confidence.
