Dental implants improve quality of life for people who loose teeth due to accidents or disease. EU-funded testing of a sample of seven dental implant fixtures sold in the EU found that they comply with selected EU standards.
The testing campaign was organised by the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
"Market surveillance campaigns like this are crucial to protect the health of consumers, and also businesses in the Single Market from unfair competition by those who do not comply with the rules. The outcome of these tests confirms that regular market surveillance campaigns are effective in enforcing standards," said Vanessa Capurso, Policy Officer at the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
The testing
An accredited laboratory tested seven samples of dental implant fixtures bought in EU/EFTA countries. The fixture is the part of the implant that is surgically implanted in the jawbone and which acts like the roots of the tooth. It is made from biocompatible material, like titanium or zirconia, and has a threaded or roughened surface to promote integration with the bone. Only the fixture was tested as this part of the dental prosthetic is in direct contact with tissue and bone of the patient.
The other two parts of the implant: the dental prosthetic (the visible part of the tooth) and the abutment, which connects the prosthetic with the fixture, were excluded from the product testing.
Laboratory results
An accredited laboratory did tests to determine chemical properties; cytotoxicity, or the potential of the materials used in the fixture to harm living cells; sterility and the presence of bacterial endotoxins.
All samples passed.
Three samples were found to contain compounds at levels exceeding the acceptable exposure threshold, but that were below the toxicological screening limit. If a chemical constituent is under this limit, it is not considered harmful to genes, reproductive health, or be carcinogenic.
In another sample, nickel was identified as a suspected carcinogen associated with inhalation exposure. According to the laboratory test results, it was not considered harmful because there was no risk of it being released.
Warnings, markings and instructions
In addition, market surveillance authorities examined the warnings, markings and instructions on the packaging of the samples. Four of the samples met the requirements, three did not.
The problems found were: warnings and instructions were not in the required languages, the sterile packaging lacked reference to the instructions for use, mention of a prohibition to reprocess was in Portuguese only, and reference to incident reporting was not compliant.
Market surveillance authorities ordered manufacturers to ensure that the instructions for use are translated into the required language(s) and to provide accurate and complete information about incident reporting.
A coordinated effort
The testing was part of the Joint Actions on Compliance of Products (JACOP). Market surveillance authorities across the EU jointly selected and checked the compliance of products sold on the Single Market with selected EU standards.
Dental implant fixtures were one of the 16 product categories inspected in this EU-funded campaign.
While the test results did not show any non-compliance, manufacturers and market surveillance authorities are encouraged to continue monitoring these products.
More information
Details
- Publication date
- 16 June 2025
- Author
- Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs