Safety information regarding counterfeit dental resins from the manufacturer "Thermoplastic Comfort Systems, Inc." New
The Federal Office for Safety in Health Care (BASG) has been informed that the following products have been counterfeited:
- Unbreakable by TCS
- IFlex by TCS
- Karadent by TCS
The products of the manufacturer "Thermoplastic Comfort Systems, Inc.", 2619 Lime Avenue, Signal Hill, California, in the United States of America, are dental materials and are used for the manufacture of dental prostheses.
There is a potential health risk as the safety and effectiveness of counterfeit products is not guaranteed.
According to the manufacturer, counterfeits can be recognised by the following feature:
| Original TCS product label | Counterfeit product label |
| CE marking only, no number of a notified body | CE marking with number of a notified body 0050 |
| (The product is declared by the manufacturer as a Class I medical device (MDR), therefore no Notified Body is required) | (see red marking on the product images) |
Actions to be taken by distributors, customers and healthcare professionals: Verify the authenticity of all TCS products in your inventory or supply chain. Contact TCS directly if you have concerns about product authenticity and report suspected counterfeits.
The BASG asks you to report any suspicious activities in connection with the above-mentioned products by e-mail to the BASG(medizinprodukte@basg.gv.at) and the manufacturer (contact person: Marilin S Posca; marilin@tcsdentalinc.com).
| Medical devices | • Unbreakable by TCS • IFlex by TCS • Karadent by TCS |
|---|---|
| Manufacturer | Thermoplastic Comfort Systems, Inc. |
