ZIRCONIA DENT COMPANY LTD

Zirconia Dent Company Ltd specializes in dental devices, including composite filling and restorative instruments, extraction forceps for specific teeth (such as upper incisors, canines, and molars), and impression trays (e.g., U1, U2, U3). They also produce specialized tools like the Eccesso-ZLM 6840, Fissura-ZLM 6842, and Misura-ZLM 6841, which are likely used in dental preparation, measurement, or restoration procedures. Their portfolio covers both tools and materials essential for dental treatments.

Zirconia Dent Company Ltd is based in Pakistan. While the company’s location does not inherently determine regulatory classification, it must ensure its devices comply with the applicable regulations of the markets where they are sold—such as the EU’s Medical Device Regulation (MDR) if targeting European markets. Their devices are listed in the EUDAMED database, indicating they are registered for the EU market under relevant requirements.

Zirconia Dent Company Ltd’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry is used to track devices that have undergone regulatory procedures like conformity assessment or declaration of conformity under EU laws. Listing in EUDAMED confirms the company’s devices meet the necessary requirements for placement on the European market, particularly under the MDR framework.

All of Zirconia Dent Company Ltd’s listed devices fall under Class I classification. This classification applies to low-risk devices, such as many dental instruments and materials, which typically do not require invasive procedures or pose significant health risks. Class I devices still must comply with essential safety and performance requirements but often undergo less stringent scrutiny than higher-risk classes (e.g., Class II or III).