Prosthesis, Orthodontic
Who Makes This Device Type in China?
29 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hong Kong and Xinjiang. 3 of them are contract manufacturers, able to build to a buyer’s own specification.
- Bright Dental LAB Guangdong
- CBD Dental LAB, Inc Guangdong
- Creator Digital Dental Technology Co., Ltd. Guangdong
- DDS Lab China Co., Ltd. Guangdong, 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
- 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
- Northstar Trade Co., Limited Hong Kong
- Quadrant Dental LAB Limited Hong Kong
- Royal Dental Lab Guangdong
- Shen FU Arts LAB Guangdong
- Shenzhen HLD Dental&Technology Co., Ltd. Guangdong
- Shenzhen Jinyi Medical Technology Co., Ltd. Guangdong
- Shenzhen Times Dental LAB Guangdong
- Shimmer Computerized Dental Technology Co., Ltd. Guangdong, contract manufacturer
- Smile Dental Laboratory Company Limited Guangdong
- Tin Lok (Dongguan) Dental Laboratory Company Limited Guangdong
- Veden Dental Labs Inc Guangdong, contract manufacturer
- Vico Dental Technology Co., Ltd. Guangdong
- ZH Graceful Dental LAB Co., Ltd. Guangdong
- Zhuhai Crystal Dental Technology Co., Ltd. Guangdong, contract manufacturer
- Zhuhai MJ Dental Laboratory Guangdong
What Is It?
Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
What Is FDA Product Code NSR?
Prosthesis, Orthodontic is FDA product code NSR, not classified.
What Does It Take to Sell It in the United States?
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 2005. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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