Engineered with proof.
Every Nivellipso product is backed by independent lab testing, peer-reviewed studies and the regulatory rigour of a Swiss medical-device manufacturer. The data we don't publish, we send you on request.
Solothurn QC, ISO 13485:2016 lab
Independently verified
Our quality management system for medical device design, development and production is independently audited by BSI Group.
All Class IIa devices carry CE marking under EU MDR 2017/745, verified by TÜV SÜD as notified body.
Helix aligners and sapphire brackets are FDA 510(k) cleared for the US market. Clearance documents available on request.
Full post-market surveillance programme in place; PMCF summary filed quarterly with Swissmedic and BSI.
The numbers
Optical metrology, automated SPC sampling
Selected publications
Helix Aligner Treatment Efficacy — Prospective Multicenter Study, 2024
n = 312 patients, 14 practices, 18-month follow-up. Mean PAR score reduction 79.4% (±6.2%). Chair-time 23% lower than fixed-appliance benchmarks.
Sapphire Bracket Friction Coefficient versus Ceramic Alternatives, 2023
In vitro pin-on-disk tribometry. Single-crystal sapphire: 0.068 µ vs polycrystalline ceramic mean 0.142 µ — 52% reduction in kinetic friction.
NiTi Archwire Force-Deflection Comparison Across Manufacturers, 2022
ISO 15841 three-point bending at 37 °C. NV-NI-014 batch-to-batch CV: 3.1% vs competitor mean 8.7% — measurably tighter consistency.
Full technical dossier on request
Clinical practices can request the full technical dossier — mechanical test data, biocompatibility certificates, and post-market surveillance summaries — by contacting research@nivellipso.com. Professional licence verification required.
Last updated: 2026-05-21