One of the cornerstones of excellence in care at Ardentis Cliniques Dentaires is the use of medical devices and dental products of the highest quality.
Switzerland is a global leader in the medical device industry, with 1,350 companies and 54,500 employees operating in the sector [1]. Oversight is provided by Swissmedic, whose main mission is to regulate and supervise the industry. Medical devices must comply with the Therapeutic Products Act (TPA; RS 812.213), the Medical Devices Ordinance (MedDO; RS 812.213), and the European Union Regulations (EU 2017/745 and EU 2017/746) [2].
A dental implant is considered a medical device, defined as:
“an instrument, apparatus, appliance, software, substance, accessory or other medical-technical utensil intended specifically for diagnostic or therapeutic use, the principal intended effect of which in or on the human body is not achieved by pharmacological, immunological or metabolic means” [3].
There is a wide range of implant systems on the market (originating from Italy, France, Korea, etc.). At Ardentis, we prioritize Swiss-made quality. For over twenty years, we have worked with Straumann AG, a Swiss company based in Basel and the global leader in dental implants.
Straumann AG fully complies with European regulations and standards at every stage of production. Its implants, manufactured in Switzerland, meet all EU requirements and are traceable and quality-assured at all times. Straumann dental implants come with a lifetime guarantee (replacement by an equivalent implant and abutment, if final restoration has been completed) [4].
They are made of grade IV titanium or Roxolid®, a zirconium-titanium alloy with high mechanical strength and excellent osseointegration properties. Straumann implants are widely used in Swiss university hospitals and dental schools.
Each implant is fully traceable from the manufacturing site to the Ardentis clinic where it is placed. At Ardentis, we follow a strict protocol to ensure transparent traceability. Implant reference, lot number, material, surface treatment, length, and date of placement are all recorded in the patient’s medical file.
Ardentis also conducts an annual review of all implant placements, including the rare cases of complications or failures, in the presence of implant specialists and clinicians involved in implant dentistry.
Furthermore, Ardentis contributes to scientific research in implantology to validate and reinforce its choice of implant systems. Clinical studies have confirmed the high success rates and long-term reliability of Straumann implants. Ardentis Cliniques Dentaires has collaborated with Straumann AG on optimizing implant surfaces and on implant placement in specific clinical indications [5].
By Nathalie Nurdin, PhD, Ardentis Cliniques Dentaires, June 2019
References:
[1] 2016 Data. Tamedia SA, 20 minutes, March 6, 2019. Retrieved from https://www.20min.ch/ro/news/suisse/story/Implants-et-protheses-seront-mieux-contr-les-15152719
[2] Swissmedic – Swiss Agency for Therapeutic Products. Medical Device Regulation. Retrieved from https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html
[3] Art. 1, para. 1 MedDO
[4] Straumann AG
[5] Ardentis Cliniques Dentaires – Scientific publications
