CerMark and Food Contact, Implants, FDA approval

FDA Approval

         Our Cermark products, when used for marking, are not part of the design of the device or utensil. Cermark is applied to the device or utensil for marking with the laser. At Jorlink we are ask about FDA approval for the application use of Cermark. FDA approval must be part of the manufacturing process before the Cermark application is applied.

Cermark is used for marking a variety of materials. The most common use of Cermark application are the marking of medical and other surgical devices and instruments, as well as dental instruments. Cermark applications are also used for making human implants (Titanium), kitchen knives, plates, forks, cutlery, wine glasses, and glasses in general. Many of our customers have obtained FDA approval for each of their applications, as part of the process and finished product.

Passivation (ASTM A 967) and Citric corrosion (ASTM A380) tests including toxicity, heat cycling, abrasion, acidity, alkalinity, and oxidation tests have been passed. Laser marks made with Cermark have also withstood cleaning and autoclave sterilization cycles.

Because there are so many applications in which Cermark is used for marking, it is not possible for the FDA to give their approval for each mark made with the Cermark application. We do not recommend the Cermark application when used to laser mark products made for human or animal consumption. The Cermark application is not a product made for human or animal consumption. However, materials marked with the Cermark application, have been evaluated for health risk. especially when marking materials such as utensils, medical devices, or other material products used by humans or animals. If the laser is set at the appropriate laser settings the Cermark application has not presented any health risk up to this moment.

For marking stainless steel, we recommend LMM14, LMM6000 and New Ultra.

LMM6018 tape is recommended for anodized aluminum.

LMM-14, New Ultra and LMM-6000 come in aerosol which make it easy for you to use to create laser marks on Stainless Steel