The party revealed that there are major health hazards in dentures that are usually replaced in dental clinics and stomatological hospitals.
CCTV Financial Channel 315 reporters went deep into some denture production factories and found that these manufacturers used the broken metal without any mark or medical device registration license number when casting the denture bracket. According to experts, these broken steels are either recycled materials or industrial raw materials. Moreover, they are often recycled and reused, and the concentration of harmful elements is getting higher and higher, which is harmful to the human body! Moreover, these dentures are not sterilized, and they are sent to you with an old Toothbrush used by employees. Do you dare to use such dentures?
The reporter was hired to enter Beikou Denture Technology Research Co., Ltd., a professional enterprise that provides denture processing services for many medical institutions. The company has legal medical device manufacturing qualifications.
According to the process, the North Denture will produce dentures according to the order sent by the hospital. The hospital will indicate the materials required for the denture on these orders: cobalt chromium, pure titanium, nobelin and so on. On the floor of the foundry, a stent-filling mold made of dental molds from hospitals in various hospitals was piled up.
The reporter saw that the metal materials used by the workers to cast ordinary brackets were irregular in shape and size, and there was no sign. What kind of material is this? Is it in line with national standards? The reporter entered the raw material warehouse of the company, but did not find such raw materials, even the old employees of the factory felt a little embarrassed.
Workers at Beikou Denture Technology Research Co., Ltd.: "(Which factory are you using now?) I don't know, during this time, the material on the box is directly buckled, and it is directly inside the bag. See what is going on."
The reporter noticed that the foundry workers occasionally used some completely different metal materials. The label of the medical device is printed on the box of the metal material. Each metal material is uniform in shape and size, and is printed with relevant signs. It turned out that this is the formal denture metal raw material. According to the national requirements, customized dentures belong to the second category of medical device products. As a product of the entrance, the metal material of the denture may be degraded and corroded in the oral environment, and may even irritate the gums and appear red and swollen. According to the "Guidelines for the Technical Review of Registration of Custom Denture Products" issued by the State Food and Drug Administration: "The production of dentures should use materials such as dental ceramics and dental casting alloys with medical device registration certificates." However, in the case of the north denture casting denture bracket, the most used is the metal material with irregular shape and no mark.
In the foundry of Porcelain loyalty Medical Products Co., Ltd., the reporter also saw this irregularly shaped metal material, which workers are using to cast denture brackets.
The head of the quality inspection department of Porcelain loyal Medical Products Co., Ltd.: "The big and the small are not the same kind, the industry is the broken steel, the second."
The head of the quality inspection department of this company told reporters that this irregularly shaped metal raw material is called broken steel in the industry and its quality is relatively poor. It is generally used to make ordinary brackets with relatively low price.
Porcelain loyal medical supplies Co., Ltd. workers: "(What kind of material is this?) This is steel, brackets (to make brackets)."
At the porcelain loyalty processing factory, the reporter finally saw the box of this scrap steel raw material, which has neither Chinese characters, instructions and labels, nor a medical device registration license number. According to the “Notice on Strengthening the Supervision of Customized Denture Production” issued by the State Food and Drug Administration and the “Regulations on the Management of Medical Device Manuals and Labels”: “Do not use unregistered denture materials to process custom dentures”; where the Chinese people Medical devices sold and used in the Republic shall be accompanied by instructions and labels. The text of the manual and label should be in Chinese. Then, where did these unclear broken steels come from?
Guobang Medical Devices City is a large-scale specialized market for medical device wholesale. The reporter here also saw that the scrap steel was on sale. Under the introduction of the store, the reporter saw a boss in the rental house in Foshan City. Here, the reporter saw the same scrap steel materials used in the packaging used by Porcelain Zhongzheng Medical Products Co., Ltd.
The owner of the denture shredder raw material wholesaler Hou: "This is more than 90% of the domestic production in Tianjin, because only Tianjin has this, how many tons of he is there in a month, so do it."
Hou Bo told reporters that the shredded steel on the market is basically shipped from Tianjin. As for the accurate manufacturer, no one knows.
Hou Bo, a wholesaler of denture shredded steel raw materials: "I have been working with him for seven or eight years now, and I have never seen the boss. Because there is no card in this thing, there are too many things mixed with him. His quantity is large. He is also afraid of an accident."
Hou Bo said that many domestic denture processing plants use this shredded steel raw material to cast denture brackets. Its market price is only one-seventh of that of regular manufacturers. Why is the price of scrap steel raw materials so cheap? Professor Zhao Xinyi, member of the National Standardization Committee for Oral Materials and Equipment, gave this answer.
