It is reported that the State Drug Administration recently issued a notice to give the latest definition results for the classification of medical devices, which mentioned that 197 products are not recommended to be managed as medical devices, involving a variety of oral related consumables. Are you concerned about which commonly used oral medical devices may face “delisting”? Let’s find out.
On May 17, 2022, the Medical Device Standards Management Center of the National Medical Products Administration released the “Summary of Medical Device Classification and Definition Results from 2020 to 2021” on its official website, including a total of 1,077 medical device products. The classification of some dental medical devices has changed, covering multiple clinical and technical departments.
As mentioned in this summary, 155 products are recommended to be managed according to Class III medical devices, 505 products are recommended to be managed according to Class II medical devices, 143 products are recommended to be managed according to Class I medical devices, 51 products are not recommended to be managed as medical devices alone, 197 products are not recommended to be managed as medical devices, and 20 products are recommended to define management attributes according to the judgment procedures for drug-device combination products. It is recommended to have 6 products depending on the situation.
In this regard, the editor has specially sorted out the products related to oral medical care in each category, and excerpted the more important products that readers may be concerned about as follows for your reference and understanding.
It is not recommended to be a product that is regulated as a medical device
Excerpts and descriptions of oral related products are as follows:
3D printing resin tray material is used in stomatology to make bleaching trays or transfer trays through the 3D printing process.
Medical non-woven packaging materials are used for wrapping medical devices when medical institutions disinfect medical devices in the supply room to achieve isolation and prevent cross-infection.
Non-woven fabric for sterilization is used in the sterilization process to wrap the diagnostic and treatment instruments, utensils and articles used in the hospital after disinfection or sterilization.
Sterilization absorbent paper is spread flat at the bottom of the metal basket for sterilization of surgical instruments, and the surgical instruments to be sterilized are placed on the absorbent paper, and then wrapped with a cloth or non-woven fabric for sterilization to assemble a sterilization package.
Sterilization box is used to pack surgical instruments for easy transportation, or used to hold surgical instruments, and clean, disinfect and sterilize, preserve, reuse and other operations of the instruments in the box in the packed state.
Saline Cleansing Solution is composed of 0.9% sodium chloride and sterile purified water, which is used to cleanse and moisturize the face, ears and navel of ordinary healthy people.
The customized sports protector is used for the mouth guard during exercise, worn on the upper and lower teeth to prevent direct contact between the upper and lower teeth, and uses the high elasticity of the guard to reduce the damage to the teeth caused by the instantaneous force during the impact of movement.
3D printing implant surgical guide material is used to make implant surgical guide through 3D printing technology.
The guide ring reamer in the dental science and technology laboratory is used in the dental science and technology laboratory to trim the hole position of the implant guide plate and reduce the surface roughness of the processed hole.
Dental implant surgery goggles are used to protect the patient’s eyes from debris and water splashing into the patient’s eye during the dental implant procedure. It is also used to reduce eye strain on patients caused by overhead LED lighting.
Dental tray U-shaped, used to carry the tooth bleaching glue with a hydrogen peroxide content of 3.0%, isolate the tooth bleaching glue from the saliva in the mouth, prevent the tooth whitening glue from being diluted by saliva, make the whitening glue fully contact with the tooth surface, soak it, and let the patient bite for 30~60 minutes for tooth bleaching. Do not work with dental cold light therapy devices.
Fuel glue is used in the dental laboratory, which is filled inside the restoration, which is fixed to the support handle by its viscosity, glazed on the surface of the restoration and sintered in a porcelain oven. After sintering, it adheres to the restoration in the form of cotton wool, which is removed from the restoration by a steam cleaner, leaving no residue on the restoration and not entering the human body.
Dental denture forming solution is used in the process of denture processing, mixed with porcelain powder, mixed with porcelain powder into a paste, so that the denture can be shaped. After high-temperature sintering, the dental denture forming solution in the denture is volatilized, and there is no residue and will not be implanted with the denture.
Teeth whitening essence is composed of carbamide peroxide (equivalent to 2.9% hydrogen peroxide), water, ammonia, polyacrylic acid, peppermint oil. Do not use with dental cold light whitening device. Place in a tray (passive product) and wear it in your mouth, or apply it directly to the tooth surface and rinse your mouth after use.
The position positioner for dental laboratories is used to temporarily connect the substitute and install the substitute on the 3D printed dental model, and the substitute can be removed after fixing the substitute to the model with screws. It is only used in the dental laboratory.
The reamer for the dental laboratory is used to trim the implant hole inside the 3D printed model and reduce the surface roughness of the processed hole. For use in dental laboratories only.
The special cleaning and lubrication machine for dental handpieces is used to lubricate and clean the inside of dental handpieces.
Mouth and nose sprays are used to prevent pathogenic airborne microorganisms from adhering to the mucosal tissue surfaces of the oral cavity and nasal cavity, reducing the load of pathogenic microorganisms and preventing infection.
Handpiece Cleaning Lubricant is used for the cleaning and/or lubrication of handpieces.
The disposable medical mask inner cushion bracket is placed between the mouth and nose and the medical mask, so that a gap is created between the mask and the mouth and nose. Under the condition that it does not affect the use of masks, it can prevent stuffiness, make breathing smoother, and enhance ventilation, such as when people wearing glasses use it, it can prevent fogging of glasses lenses.
External Denture or Braces Cleaning Gel is used to clean dentures and braces outside the mouth and rinse with clean water after cleaning.
External Denture Cleaning Tablets For cleaning dental dentures, dissolve the antibacterial cleaning tablets in purified water, then soak the dentures to be cleaned for more than 15 minutes, remove the dentures and rinse them with water.
Occlusal bracket for dental science laboratory When making denture dental molds in dental science laboratory, it is used to imitate the upper and lower jaw and temporomandibular joints of the human body, fix the upper and lower jaw models and occlusal supports, and can also simulate the movement of the lower jaw to realize the transfer of occlusal relationship.
Oral gargle powder Dissolve oral gargle powder in water, rinse in the mouth and spit it out. It is used for temporary dry mouth in the perioperative period, as well as for long-term dry mouth due to damage to the salivary glands.
Probiotic metabolites root canal irrigation solution is used to kill or inhibit the common infectious flora in the root canal and maintain the health of the oral microecology.
Nucleic acid sampling workstation Nucleic acid sampling staff conduct sampling operations through protective gloves in the workstation
Appliance Sticker The appliance wearer or guardian attaches the sticker to the anterior teeth of the appliance according to the instructions.
Big Data Artificial Intelligence Scientific Research Platform After reading the uploaded medical image data, the software annotates, processes and analyzes the characteristics of the images, and can statistically model the data through radiomics or deep learning algorithms, so as to help doctors reduce the workload of scientific research and improve the efficiency of scientific research results. The software is for scientific research purposes only.
Products that are recommended to be managed in accordance with Class III medical devices
An excerpt of oral related products and descriptions is as follows:
Implant prosthetic abutments or implant abutment superstructures are placed on implants or abutments to connect, support and retain restorations (crowns, bridges) and restore the form and function of missing teeth.
Implant cannula and screws are used in the immediate and delayed temporary restoration process of oral implantation, where the prosthetic cannula is connected with the temporary denture of implant restoration as a part of the temporary denture, so as to facilitate the connection of the temporary denture and the abutment; The temporary denture is then secured with screws on the abutment of the implant supercomposite to protect the implant superstructure or to protect the abutment.
Teeth whitening gel consists of 16% carbamide peroxide (equivalent to 6% hydrogen peroxide), polyethylene glycol, polyvinylpyrrolidone, glycerin, peppermint oil (flavoring agent). Use with a dental cold light whitening device. Apply directly to the tooth surface and rinse your mouth after use.
Resin surface finishes are used to coat the surface of dental resin restorations and denture base materials, and form a film after light curing to enhance the surface finish of dental resin restorations and denture base materials.
3D printing resin material for manufacturing orthodontic support blocks and dental models The printed orthodontic support blocks are used in conjunction with the appliances to have the function of orthodontics, which are used to strengthen the firmness of the occlusal point between the appliances and the teeth, ensure that the patient has sufficient support when occlusing, improve the orthodontic efficiency, and shorten the orthodontic time.
X-ray bone age detection equipment irradiates the palms and wrists of children to obtain images, and processes the images through the convolutional neural network algorithm of the software, and gives specific conclusions about the closure degree of the epiphysis, which assists in the judgment of bone age.
Difficult airway screening instrument collects images of the patient’s head and neck, and the software uses artificial intelligence technology to identify and analyze the images to assist in determining whether the patient has a difficult airway.
Note: The national classification of medical devices
Class III medical devices are the highest level of medical devices that must be strictly controlled, which refers to medical devices implanted in the human body to support and maintain life, and their safety and effectiveness must be strictly controlled.
Class II medical devices refer to medical devices whose safety and effectiveness should be controlled. It mainly includes X-ray machine, B-ultrasound, microscope, biochemical instrument, etc.
Class I medical devices refer to medical devices that are sufficient to ensure their safety and effectiveness through routine management.
Oral related products recommended for management in accordance with Class II medical devices are: disposable medical masks (non-sterilized), electromagnetic facial arch mandibular motion measurement system, periodontal stoppers, orthodontic bracket mucosal protective silicone, oral viewers and components, personalized positioning jaw plates, film-forming oral ulcer gargle, disposable stainless steel root canal brushes, glazing materials for dentures, customized orthodontic arch expansion appliances, customized jaw reconstruction appliances, customized orthodontic appliances, bracketless transparent appliances, Dental implant surgery positioner kit, oral near-infrared light irradiation instrument, orthodontic retainer, medical molar protector, dental drill guide for implantation, mussel mucin polymer oral gel, orthodontic light curing composite resin positioning tool, oral analysis test strip, etc.There are many oral related products recommended to be managed in accordance with Class I medical devices, and interested dentists can check it from the official website~
The state’s classification supervision and management of medical devices is to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry. According to the different classifications of medical devices, the management requirements for the scope of licensing, business premises, and personnel qualifications for their use are also different. The notice also pointed out that the results of the classification of relevant products do not represent the recognition of the safety and effectiveness of their products, and are only used as a reference for the registration and filing of medical device products.
These recommended “delisted” products are no longer included in the management of medical devices, which has a huge impact on the enterprises that produce and operate such products, and the medical institutions that purchase and use such products will also be more or less concerned about their trends.
