Schottlander Enigma Colour Tone, Model 0156

The Schottlander Enigma Colour Tone, Model 0156, is specifically designed to assist dental professionals in shade matching and selecting dental restorative materials. This ensures precise colour reproduction for dental restorations like crowns, veneers, and other restorative work, helping to achieve natural-looking and consistent results.

The device is explicitly stated as suitable for both single-use and reusable applications in dental settings. This flexibility allows clinics to choose the most practical option based on their workflow and infection control protocols.

The device received FDA 510(k) clearance under the Traditional pathway on June 16, 2000, with a clearance type classified as *Substantially Equivalent* (SESE). It also complies with the Medical Device Directive (MDD) standards in Europe, ensuring alignment with both U.S. and EU regulatory requirements.

The device is supplied by Davis Schottlander & Davis Ltd, though specific packaging details (e.g., sterilization packaging, individual kits) are not provided. Since it is reusable, proper cleaning, disinfection, and storage per dental infection control guidelines are critical. If single-use, follow manufacturer instructions for disposal to maintain sterility and compliance.