Restoration, Porcelain
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Hong Kong and Beijing, and 5 other provinces: 50 hold an FDA registration. 6 are contract manufacturers.
- ADS Dental LAB Ltd. Guangdong
- Beijing Yingguan Dental Science&Technology Co., Ltd. Beijing
- BMF Tech (Zhuhai) Inc. Guangdong, contract manufacturer
- Bright Dental LAB Guangdong
- CBD Dental LAB, Inc Guangdong
- Chengdu Besmile Medical Technology Co., Ltd. Sichuan
- Cosmos Dental Technology Guangdong, contract manufacturer
- Creator Digital Dental Technology Co., Ltd. Guangdong
- DDS Lab China Co., Ltd. Guangdong, contract manufacturer
- Dentall, Inc. Beijing, contract manufacturer
- Digital Dental Depot Guangdong, contract manufacturer
- DTS Digital Dental LAB Guangdong, contract manufacturer
- Edental LAB Co., Ltd. Guangdong, contract manufacturer
- Exceldent Dental Technology Development Co., Ltd. Guangdong, contract manufacturer
- Fseven Dental Technology Zhuhai Co., Ltd. Guangdong
- Fuzhou Rick Brown Biomaterials Co., Ltd. Fujian
- Golden Smile Dental LAB Guangdong, contract manufacturer
- Improve Co., Limited Hong Kong, contract manufacturer
- Joydenta Dental Laboratory Guangdong, contract manufacturer
- KTJ Medical Technology Co., Ltd. Guangdong, contract manufacturer
- League Dental Technology Ltd Guangdong
- Modern Dental Laboratory (DG) Co., Ltd. Guangdong, contract manufacturer
- Natural Dental Laboratory Co., Limited Xinjiang
- NEW Perfect Dental LAB Guangdong, contract manufacturer
- NEW Star Dental LAB Co., Ltd. Guangdong
- Northstar Trade Co., Limited Hong Kong
- Quadrant Dental LAB Limited Hong Kong
- Qinhuangdao Audental Metal Technology Co., Ltd. Hebei
- Rite Smile Labs Inner Mongolia, contract manufacturer
- Royal Dental Lab Guangdong
- Shen FU Arts LAB Guangdong
- Shenzhen HLD Dental&Technology Co., Ltd. Guangdong
- Shenzhen Jinyi Medical Technology Co., Ltd. Guangdong
- Shenzhen Robust Dental Laboratory Co., Limited Guangdong
- Shenzhen Times Dental LAB Guangdong
- Shenzhen Ubest Dental Co., Ltd. Guangdong
- Shenzhen Yurucheng Dental Materials Co., Ltd. Guangdong
- Shimmer Computerized Dental Technology Co., Ltd. Guangdong, contract manufacturer
- SKY Dental LAB (International) Guangdong
- Smart Dental CAD Solutions Limited Guangdong
- Smile Dental Laboratory Company Limited Guangdong
- Sunstar Trading International Limited Hong Kong
- Shenzhen Advanced Dental Laboratory Guangdong, contract manufacturer
- Tin Lok (Dongguan) Dental Laboratory Company Limited Guangdong
- Topway Dental Laboratory Co., Ltd. Guangdong
- Veden Dental Labs Inc Guangdong, contract manufacturer
- Vico Dental Technology Co., Ltd. Guangdong
- ZH Graceful Dental LAB Co., Ltd. Guangdong
- Zhuhai DS Dental Technology Co., Ltd. Guangdong
- Zhuhai MJ Dental Laboratory Guangdong
What Is This Device?
Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
How Is NSP Classified?
Restoration, Porcelain is FDA product code NSP, not classified.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.