Medical DeviceQualified Supplier Directory
Cendres+Metaux SA Company Profile
T: +41 58 360 20 00
F: +41 58 360 20 13
Rue de Boujean 122, CH-2501 Biel / Bienne, Switzerland
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe, Worldwide
You have an idea but you are not sure how to realize it? Our experienced engineering and sales team finally make things possible. They help you to establish a realistic project schedule and will supervise your project from the idea through to the successful market introduction.
Your implant design is finalized but you would still like it to be reviewed and/or optimized for production? Our competent engineering team will be most happy to assist you with all your technical inquiries.
You have never created a Device Master File before or simply have better things to do? Or you need support for the registration of your device? Our quality management and regulatory team would be pleased to give you a hand.
You have increased cleanliness requirements for your products and wish them to be produced in the right environment and being cleaned in a safely manner. Our microbiologist is constantly monitoring the production environment and validated cleaning processes and is happy to provide advise for any of your questions.
Our core competencies
- Micromechanical production of medical implants with complex geometries
- Injection molding and machining of high-performance polymers (Pekkton®, OXPEKK®)
- Surface treatments and finishes of implants
- Complementing offerings incl. laser marking, washing, simple and complex clean room assembly, testing, packaging (peel pouch, blister etc.) and inventory management.
- A modular service offering, flexible and adapted to your needs. We offer for e.g. standardized packaging systems which can give you significant financial and time advantages.
- A closed material cycle for all our precious metal alloys. From refining to foundry until production. All from one hand, under one roof.
- As your network partner we maintain and coordinate contacts throughout the whole value chain.
- Accreditation and certificates ISO 13485 / 9001 / 14001 / GMP compliant / FDA registered.
Our production capabilities
- Turned and milled parts from 42mm until 0.02mm
- Injection moulded parts up to about a size of 11 cm3
- Packaging on four cleanliness levels
- Production and storage surface: ca. 7361m2
Precious metals and precious metal alloys
Amongst others: gold, fine gold, silver, Ceramicor®, Elasticor®, Elitor®, PltIr10% (silver white), PltIr20%
Further alloys and according material data sheets can be found on our website.
Titanium und titanium alloys
- Titanium Grade 2 and 4 annealed (commercially pure Titanium (cpTi))
- Titanium Grade 4 cold drawn (cpTi with enhanced strength)
- Ti-special alloys: Titan Grade 23 (Ti6Al4V ELI), Titanium Grade
- 36 (Ti-45Nb), Nitinol (Ni-45Ti), Titanium Aluminium Nobium (Ti6Al7Nb), Titanium Niobium Zirconium (TiNbZr)
- Material characteristics: high tensile, fatigue and flexural strength, ideal dimensional stability, excellent wear and abrasion resistence, compatibility with all common sterilization methods, radio-transparent.
- Pekkton® indicated for temporary restorations as well as for long-term solutions. The material is versatile and can be variously processed (molded, pressed or machined). Thanks to 10%TiOx it is slightly whitish and, thus, meets the highest aesthetic requirements in dentistry. Pekkton® is based on OXPEKK® from OPM, Oxford Performance Materials Inc., Enfield, USA.
- OXPEKK-IG200 indicated for short and long-term implants outside the mouth. The material’s density and stiffness is similar to bone, it is chemically inert and highly resistant to abrasion. Unlike PEEK, PEKK as well displays both, amorphous and crystalline material properties and shows twice the compressive strength of PEEK.
- OXPEKK-MG200 indicated for e.g. for packaging elements. Has identical material characteristics as OXPEKK-IG200, however, it is not suitable for implantation due to the differing documentation.
For more information contact Cendres+Metaux SA