As an industrialist you wish to have your dental cements analyzed
Why analyze dental cement?
Dental cement is a medical device that requires risk assessment and biocompatibility testing prior to marketing. These analysis of dental cement as a medical device are governed by the ISO 10993 standard, and more specifically ISO 10993-18 concerning biocompatibility.
The FILAB laboratory assists you in analyzing the biocompatibility of dental cements
Analysis techniques for dental cements as medical devices
Originally, the ISO 9917-1:2003 standard specifies the requirements and test methods for liquid/powdered acid-base dental cements intended for use as sealants or coatings.
However, this standard does not specify any qualitative or quantitative requirements for the absence of biological hazards. This is why it is necessary to analyze dental cements in the same way as other medical devices thanks to the ISO 10993 standard (and more specifically 10993-18). Thus, FILAB laboratory offers its know-how for :
- Characterization of ceramics used in medical devices such as dental cement according to ISO 10993-18
- Identification and quantification of degradation products of ceramics according to ISO 10993-14
- Analysis of cleaning residues HCT / TOC
- Analysis of nanomaterials in medical devices according to ISO 10993-22
Why choose FILAB for dental cement analysis?
Laboratoire FILAB is the first French laboratory to be COFRAC ISO 17025 accredited for nanometric characterization according to ISO 10993-22. Our team of highly qualified experts is at your disposal to assist you in the analysis of your dental cements and medical devices. Thanks to our 2100m² analytical park, we adapt our techniques to your DM and not the opposite. Our service offer is tailor-made according to the specific needs of your sector.
