Device Information

Device Specifications

This dental porcelain powder is made of materials like silica (SiO₂), alumina (Al₂O₃), potassium oxide (K₂O), and others. It is used for creating dental prostheses like crowns and bridges. The product includes three components: Porcelain Powder, Stain/Glaze, and Blending Liquid. The blending liquid contains purified water, 1,3-butanediol, and diethanolamine. The Stain/Glaze is a mix of porcelain powder and the blending liquid.

Indications

This device is used as a veneering material for fixed prosthesis in dental crowns and bridges.

Intended Use

This device is intended for professional dental technicians to create crowns and bridges for patients with denture defects or missing teeth. It is used in licensed dental manufacturing facilities.

Availability

• Prescription Use. This device requires a prescription and is not available over the counter.

Study Results

• Nonclinical and Safety Testing: The device underwent physical tests for chemical composition, flexural strength, and chemical solubility. It passed all biocompatibility tests, including cytotoxicity, delayed hypersensitivity, and genotoxicity.

Regulatory Information

• Regulation Number: 21 CFR 872.6660
• Regulatory Class: Class II
• Product Code: EIH
• 510(k) Number: K232676
  This device must comply with Quality System (QS) regulations and other relevant requirements like good manufacturing practices.

Manufacturer Information

• Name: Chengdu Besmile Medical Technology Co., Ltd.
• Address: No.9, Sec. 2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District, Chengdu, Sichuan 610200, China
• Contact Person: Moushan Liu, Quality Manager

Predicate Device Information

• Primary Predicate Device: Vita VM® (K060441, K052710)
  This predicate device has the same intended use and similar materials. The primary difference lies in specific component ratios and descriptions, but this does not impact the device’s effectiveness or safety.

Implications

This device allows dental professionals to produce durable and safe dental crowns and bridges. The product’s materials and manufacturing processes are well-regulated, ensuring safety and compliance with relevant standards.

References

1. Dental Porcelain Powder. K232676. Chengdu Besmile Medical Technology Co., Ltd. FDA Summary Link. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232676