Product instructions and guarantee
The product is manufactured on the basis of an order from a dental laboratory, in line with an STL file sent by the laboratory. The product can only be used by a patient after a dental technician has fine-tuned it.
The product was made with a ConceptLaser Mlab Cusing machine using the laser melting technique. The product was manufactured by Materflow Oy.
The product will last for decades. It will not suffer damage under normal use.
The product is a bespoke product that is only to be used by the patient it was designed for. The patient’s personally identifiable information is marked on the package and the referral.
The product is made from Remanium® star CL, which is a cobalt chrome (CoCrW) alloy. For this product, CoCrW was used in powder form. The material complies with the directives DIN EN ISO 9693 / DIN EN ISO 22674, Type 5. It carries the CE mark (CE0483) and meets the requirements of ASTM standards. The material has been approved by the device manufacturer ConceptLaser for use in metal 3D printers. The material is specifically designed for use in dental products. Our equipment and manufacturing processes comply with the 93/42/EEC Medical Device Directive.
Before the product can be used by the patient, a dental technician must finish the product. The final polishing must also be performed by a dental technician. The material can be coated with ceramic materials designed for use with cobalt chrome within the linear thermal expansion range of 25–500 °C, 13.8-15.1. The linear thermal expansion factor of Remanium® star within the temperature range of 25–500 °C is 14.1. Therefore, all of the most commonly used ceramic materials are suitable for the purpose. Coating must be performed by a qualified dental technician. The finished product must be sterilized and packed in sterile packaging.
The product is not under any circumstances to be given to the patient before a dental laboratory has taken the required measures to finish it.
Once the product has been coated and sterilized, it must be delivered to the dentist to have the product fitted in the patient’s mouth.
The product is intended for the patient it was designed for and it must not be reused. If reused, it may pose a risk to the patient. The product is custom designed for a particular patient and, if reused for another patient, it may damage the patient’s teeth and mucosal membranes.
When used correctly for the intended purpose, the product does not pose any risk.
The storage temperature and location do not affect the product and the product will not suffer any damage during normal transportation.
The product was manufactured in accordance with directive 93/42/EEC and the product’s central properties comply with directive 93/42/EEC.
These instructions were inspected by Materflow Oy on 1.11.2020.
