Cavex Holland BV

Cavex Holland BV specializes in dental medical devices. Their portfolio includes fluoride-containing prophylaxis pastes for teeth cleaning, dental impression alginates (both fast-set and color-changing variants for patient comfort), dental syringes for local anesthesia, tooth-whitening correction pens, bonding agents for dental restorations, and simulated dental materials like alginate substitutes and composite analogs for training purposes. These products are designed to support dental procedures and patient care.

Cavex Holland BV is headquartered in the Netherlands, which means its devices are subject to EU Medical Device Regulations (MDR). The company’s products are classified under Class I, Class II, and Class IIa, indicating varying levels of risk and regulatory oversight. Their devices are listed in the EUDAMED database, which is the official EU registry for medical devices, ensuring transparency and traceability under EU law.

Yes, Cavex Holland BV’s devices are also listed in the FDA’s 510(k) registry. This indicates that some of their products have undergone the FDA’s premarket notification process in the United States, where they are classified similarly to their EU counterparts—primarily as Class I, Class II, or Class IIa devices. The 510(k) listing confirms their submission for market authorization in the U.S. under FDA regulations.

Cavex Holland BV’s devices are classified as Class I, Class II, or Class IIa under the EU Medical Device Regulations. This classification determines the level of scrutiny and regulatory requirements they must meet. For example, Class IIa devices—like some dental bonding agents or syringes—require additional safety and performance evaluations compared to Class I items, such as certain dental impression materials. The classification ensures appropriate oversight based on the device’s risk profile to patients.

Cavex Holland BV focuses on dental materials that address common clinical needs, such as fluoride prophylaxis pastes for cavity prevention, fast-set alginates for efficient patient impressions, and simulated materials for training (e.g., color-changing alginates or composite analogs). Their products also include tools like tooth-whitening correction pens and bonding agents, which help dental professionals deliver precise, patient-centered care. These materials are designed to improve workflow efficiency, accuracy, and patient comfort during procedures.