About Us
Topway dental lab was founded in 2006, specializing in providing outsourcing processing services for dental lab services for overseas dental labs and dental clinics. Currently, we possess a production site covering an area of 4,000 square meters, with 300 employees, and are equipped with independent dormitories and a cafeteria. Topway dental lab has been registered and has passed the US FDA certification, ISO:13485, ISO:9001, the Medical Device Production License of China, the Class II Medical Device Product Registration Certificate issued by the China Food and Drug Administration, the High-tech Enterprise Certification of China, and the Specialized, Sophisticated, Unique and Novel Enterprise Certification of China…
Detal lab services and China Spring Festival
Dental labs and dental clinics in various countries that have long cooperated with Chinese dental labs should be extremely bothered by the Chinese Spring Festival. Almost all Chinese dental labs have to face the situation that dental technicians return to their hometowns for the Spring Festival, and thus all Chinese dental labs will be greatly affected in terms of product quality and delivery time. Therefore, since 2022, we have started to make special arrangements regarding the work of dental labs during the Chinese Spring Festival in terms of staff salaries, bonuses, and vacation adjustments. We can ensure that our clients are hardly affected in terms of product quality and delivery time.
China Dental Labs in Shenzhen
The competition among dental labs in Shenzhen, China, has become extremely fierce. There are hundreds of dental labs here, big and small. The small ones may have only three to five people, while the large ones may have over two thousand employees. The vast majority of them were established within the past five years. Due to the high costs of obtaining certificates and annual fees, the vast majority of outsourcing factories neither have the domestic FDA certification in China (which takes the longest time, is under the strictest government supervision and is the most expensive), nor are registered with the US FDA, nor have they passed the ISO certification. They simply use the FDA information of third-party carriers to send packages instead of having their own factory’s FDA certification. This brings huge risks to clients. Because the US customs requires that all manufacturers and carriers of Class II medical devices must be registered with the FDA. Once it is found that the FDA certification is lacking during random inspections by the customs, the goods will surely be detained, fines will be imposed, and even more serious consequences may occur. And all consequences other than fines are unbearable for our clients.
Little Knowledge about China FDA, US FDA and ISO
Although the US FDA certification is relatively simple and quick, only requiring registration and accepting irregular factory inspections by third-party inspection agencies entrusted by the US FDA, the increasing annual fees year by year and many clients’ lack of understanding of regulations and risks make the vast majority of Chinese dental lab owners take chances and not apply for it.
Note: The official fee of FDA in 2025: $9280.
The US FDA US agent service fee in 2025: $1295.
The US FDA official fee payment handling fee in 2025: $195.
Because there are non-compliant dental labs using fake FDA certificates, or some dental labs using other factories’ FDA certificates and then photoshopping them into their own ones, to avoid possible risks, you can check the authenticity of the FDA certificates of the dental labs you cooperate with through the following link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm. Just input relevant information of the enterprise such as the enterprise name, registration number, etc. to make the query.
China FDA Certification
At least about 95% of China’s outsourcing dental labs have not obtained the China FDA certification. The process of China FDA certification is like a strengthened local version of ISO:13485 certification. Because most of the China outsourcing dental labs in Shenzhen and Zhuhai do not operate in the Chinese market and are not within the scope of the strict supervision of the China Food and Drug Administration, and the certification process is extremely complicated, time-consuming, laborious and expensive. It not only requires providing a large amount of materials but also needs to have all major raw materials and finished products inspected by government-certified third-party inspection agencies. Its contents include on-site inspections by the certification officials of the Food and Drug Administration on the production environment, production process, key processes, technicians’ professional qualification certifications, etc. After going through the long review process of about one to two years, after China dental labs obtain the certification, they still need to accept on-site inspections of different degrees and frequencies by the district-level, municipal-level, provincial-level and national-level food and drug regulatory authorities in China. To check the authenticity of the product registration certificates and production licenses of China dental labs, you can use the following link: the official website of the National Medical Products Administration of China https://www.nmpa.gov.cn/. After entering the website, click on “Medical Devices”, and then click on “Medical Device Query”, and input information such as the registration certificate number, the name of the registrant, and the product name to make the query.