Dental hospital dental implants need to apply for a medical device license?

Dental implant hospitals can process and produce dental prostheses (crowns) according to the requirements, without the need to apply for a medical device production license and medical device registration certificate. Click to apply for subsidies for dental implants

However, dental implant hospitals must meet the following two conditions: First, in accordance with the requirements of the establishment of its appropriate quality management system and maintain effective operation; Second, the self-processing and production of dental prostheses (crowns) can only be used for the hospital. The specific regulatory authority is the provincial Drug Administration.

Regulatory basis: the former State Food and Drug Administration "on the strengthening of custom-made denture production and supervision of the notice" (State Food and Drug Administration Measures [2009] No. 336) Article III: "Third, the medical institutions belonging to the oral cavity technician room processing customized denture only for the use of this unit, and should be in accordance with the "medical device quality management system for the requirements of the regulations" ( YY/T0287-2003), the establishment of its appropriate quality management system, to maintain effective operation; such as accepting other medical institutions commissioned the production of customized denture should be obtained "Medical Device Manufacturer License" and "Medical Device Product Registration Certificate.

Beijing Sino Stomatological Hospital is a third-class stomatological hospital, as the current more famous one designated organization, more reliable. The hospital from implantation to restoration has always been the use of more risk-reducing medical system, so that each dental implant surgery can get a successful fruit, and the use of personalized surgical program, taking into full account the chewing habits of the lovers, to ensure that the upper and lower teeth in the bite of the comfort, and for so many years, there are a lot of people come to the hospital to do the surgery. And the hospital actively responded to the call of the new policy of collection, half-port full mouth implant subsidies increased to 3-10 million yuan.