3M Espe AG

3M Espe AG specializes in dental devices, including adhesives like the ADHESIVE EXL-759, dental shade guides such as the HEISENBERG EFFECT SHADES, dental lighting systems (e.g., FLASH BITE and FLASH PENTA MB QUICK), dyeing liquids (HEISENBERG DYEING LIQUIDS), and dental bonding agents like the SUGLUE-10. These products are designed to support dental procedures and aesthetics.

3M Espe AG is headquartered in the United States. The company’s location is relevant for regulatory compliance and customer inquiries, as it operates within the U.S. jurisdiction for its medical device offerings.

All devices produced by 3M Espe AG fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as dental adhesives, lighting systems, and shade guides.

Yes, the devices manufactured by 3M Espe AG are listed via 510(k) clearance in the FDA’s regulatory database. This process demonstrates that the company has submitted evidence to the FDA showing their devices are substantially equivalent to legally marketed predicate devices, meeting applicable safety and performance requirements.