SHANDONG HUGE DENTAL MATERIAL CORPORATION

Shandong Huge Dental Material Corporation specializes in dental materials and appliances, including preformed complete dentures, temporary dental crowns and bridges, reusable mouthguards, and silicone-based impression materials. Their portfolio also includes resin artificial teeth, ceramic fabrication materials for dental appliances, glass ionomer dental cement, and dental casting wax. These products are designed for restorative and protective dental procedures.

The company is based in the United States. This location influences its regulatory compliance, particularly with U.S. medical device requirements such as those enforced by the FDA.

The company’s devices are listed in the FDA’s Unique Device Identification (UDI) registry. This registry ensures traceability and compliance with U.S. medical device regulations, helping healthcare providers and regulators verify product details.

The company’s devices fall under three classification categories: Class I (generally low-risk), Class II (moderate-risk with special controls), and unclassified (U) devices. Classification depends on factors like the device’s intended use, potential risks, and regulatory requirements, ensuring appropriate oversight for patient safety.