Grouping medical devices as Dental Grouping Terms (DGT)
Dental devices with the same product owner that fall under risk classification Class B, with intended purposes that fall within the descriptor of one Dental Grouping Term.
Dental Grouping Term requirements
You can group dental medical devices of the same risk classification (Class B only) and register them under one Dental Grouping Term (DGT). Accessories of the same or lower risk class may be included in the DGT.
Note: Devices listed in the SMDR under the DGT grouping cannot be changed to a Family grouping.
Each device in the application must belong to the same product owner and has to fall within the same DGT, according to the list of DGTs and their descriptors in the table below
Adhesive kit for dental composite
A kit/pack that contains a collection of devices intended to be used to bond attachments, such as hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment.
Cryoanaesthesia device, dental
A dental brace-like device that is chilled to freezing/subfreezing temperatures and then applied to the labial sulci (gums) in a patient's mouth for a period to provide a cold anaesthesia for the underlying nerves. This device may be used as a substitute for hypodermic drug delivery during dental procedures.
Cryogenic spray, dental
A refrigerant used to cool down a tooth by spraying on it, mainly to find out if the pulp is vital. It can also be used as a local anaesthetic when extracting deciduous teeth in children.
Cusps, dental
A device designed to provide an artificial projection on the chewing surface of the tooth to achieve a proper bite.
Dental abrasives
A dental material which can be applied with an appropriate device to the surface of teeth or dental devices for prophylactic and/or treatment applications. This includes removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. It may include accessories required for dental abrasion.
Dental absorbent
Non medicated device intended to be used to absorb fluids during dental procedures.
Dental adhesives/primers
A material used as a bond-promoting substance between dental materials. It does not include cements.
Dental broach
A device designed with an abrasive outer surface to cut, open, enlarge, resurface with precision holes in hard tissue (e.g. bones, root canals), extirpating pulp and/or for exploring the root canal.
Dental burs
A rotary cutting device designed to fit into a dental handpiece and intended to cut hard structures in the mouth (e.g. teeth or bone).
Dental caries detector, electrical impedance
A device designed to measure resistance to the flow of electric current across teeth for the diagnosis of early stage dental caries and/or to monitor the progress of caries (carious areas being less resistant due to higher concentrations of fluid).
Dental caries detector, optical induced fluorescence
A device designed to determine the changes in the fluorescence of teeth enamel and dentine due to mineral loss, mainly for the diagnosis of early stage dental caries and/or to monitor the progress of caries.
Dental caries removal solution
A substance used to detect and remove caries from an infected tooth.
Dental casting materials
Compounds associated with the formation of a dental cast, i.e. a positive copy of a part of the oral anatomy made in an impression (mould).
Dental cavity liner
A substance intended to be applied to the interior of a prepared cavity before insertion of restorative material, to protect the pulp of a tooth from chemical irritation.
Dental cement
Compounds used to bond a dental prosthesis to the anatomy (luting agent), to form an insulating layer under dental restorations. It may include accessories to complete the cementing procedure.
Dental cement kit
A kit/pack that contains a collection of components designed to complete a cementing procedure.
Dental crowns/ bridges
A material used to manufacture partial or full crowns and bridges.
Dental disinfectants
A substance that destroys harmful microorganisms or inhibits their activity on medical devices which are specific for dental purposes or for use in dental procedures. It is not intended for disinfection as end point of processing.
Dental dry field device
A device used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It forms a frame around the oral cavity and provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue and removing saliva during various procedures.
Dental dry field kit
A kit/pack containing a collection of devices used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue and removing saliva during various procedures.
Dental etching composite
A device used to create a retentive surface for a composite, an adhesive or a pit and fissure sealant.
Dental file
A device that is intended for smoothing, filing or cutting during dental procedure and typically have various forms of fine-ridged cutting surfaces along part or all of their working length. This device may be used to remove gross supraginival calculus, smooth the cementoenamel junction (CEJ), finish the margins of the teeth or other dental restorations or enlarge the root canal.
Dental implant debridement brush
A rotary dental instrument designed for the debridement of a patient's dental implants affected by peri-implantitis.
Dental implant extractor
A device used to retrieve a dental implant from the oral cavity.
Dental implant, accessories
Devices designed to provide support and a means of retention for a dental prosthesis during surgical placement of a dental implant into the alveolar and/or basal bone of the mandible or maxilla.
Dental implant, prosthetic teeth bar
A small rod that bears prosthetic teeth and allows them to be attached to the dental implant abutments.
Dental implant, suprastructure
A prefabricated device that is incorporated into, or creates, a suprastructure on dental implants to mimic preparations of natural teeth.
Dental implant/ prosthesis, surgical procedure kit
A kit/pack that contains a collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals.
Dental precision attachments
Dental devices designed for attaching fixed or removable prostheses to the crown of an abutment tooth, dental restoration (including implants), or dental appliance.
Dental procedure console and accessories, hydraulic
An assembly of devices designed to bore/excavate bones, teeth and tough tissue during a dental surgical procedure. The system is powered by pressurized water via a connecting hose to the hand-piece/motor's water-driven turbine.
Dental procedure console and accessories, line-powered
An assembly of devices designed to bore/excavate bones, teeth and tough tissue during a dental surgical procedure. This system is electrically-powered and supplies the hand piece/motor with low-voltage electricity through a control unit.
Dental procedure console and accessories, pneumatic
An assembly of devices designed to bore/excavate bones, teeth and tough tissue during a dental surgical procedure. The system is pneumatically-powered.
Dental procedure handpiece, hydraulic
A hand-held dental device that includes a chuck for attaching dental drills, burs, reamers and similar rotating instruments used to bore/excavate bones, teeth and tough tissues in dentistry. The device is driven by a source of pressurized water.
Dental procedure handpiece, line-powered
A hand-held dental device that includes a chuck or collet for attaching a dental drill, bur, reamer and similar rotating instruments used to bore/excavate bones, teeth and tough tissues in dentistry. It is powered by a low-voltage electric micro-motor that is an integral part of the device.
Dental procedure handpiece, pneumatic
A hand-held dental device that includes a chuck for attaching dental drills, burs, reamers and similar rotating instruments used to bore/excavate bones, teeth and tough tissues in dentistry. It is pneumatically powered.
Dental pulp testing electrode gel
A gel meant for application to the surface of a tooth as an electric current conduction aid before using a pulp tester.
Dental pulp-capping material
A dental compound designed to cover exposed or nearly-exposed dental pulp (e.g. due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses.
Dental reamer
A device designed with fine-toothed cutting edges to cut, open, enlarge openings in, and/or resurface hard tissue (e.g. bones, root canals) with precision.
Dental reinforcing fibre
A device used in general restorative dentistry and orthodontic treatment as reinforcement of dental materials, used for the construction of dental prostheses. It may also be used for the stabilisation of avulsed teeth maintaining diastema closure or split-tooth syndrome.
Dental restorative/ cavity varnish
A substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration for the protection of pulpal tissue and to provide a marginal seal to newly-placed amalgam restorations.
Dental restorative/ repair materials
A substances intended to fill dental cavities, seal pits and fissures, restore damaged dental tissues or for inlays, onlays and veneering. It may include accessories that are used specifically with the materials. It does not include obturation of root canal.
Dental restorative/ repair kit
A kit/pack that contains a collection of devices designed to fill dental cavities, seal pits and fissures, restore damaged dental tissues or for inlays, onlays and veneering, but not for obturation of root canals.
Dental retention pin
A device intended to be placed permanently in the tooth to provide retention and/or stabilisation of dental restorations, e.g. fillings or crowns.
Dental retention pin kit
A kit/pack that contains a collection of devices intended for the insertion of permanent pins in healthy dentin to provide retention and/or stabilization of dental restorations, e.g. fillings and crowns.
Dental scalers, pneumatic
Scaler tips/inserts which may consist of handpieces that are designed to use compressed air to generate a vibrating action at its point of patient contact for the removal of accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy.
Dental scalers, rotary
Scaler tips/inserts which may consist of handpieces that provide rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy.
Dental scalers, ultrasonic
Scaler tips/inserts (which function as part of an ultrasonic scaler system) which may consist of handpieces that together transmit ultrasonic energy from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal (gum) therapy.
Dental scaling system, pneumatic
An assembly of devices designed to use compressed air to generate vibrations for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy. The hand-piece may connect to an existing air-driven hand-piece tubing and the water spray for lavage. The device is used for procedures that may involve the removal of plaque, biofilm or gross calculus from shallow to deep periodontal pockets. It can also be used for the removal of orthodontic cement.
Dental scaling system, rotary
An assembly of powered dental handpieces that provides a rotating and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. The device is used for procedures that may involve the removal of plaque, biofilm or gross calculus from shallow to deep periodontal pockets. It can also be used for the removal of orthodontic cement.
Dental scaling system, ultrasonic
An assembly of devices that uses ultrasonic energy at its point of patient contact to remove accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This device is used for procedures that may involve the removal of plaque, biofilm or gross calculus from shallow to deep periodontal pockets. It can also be used for the removal of orthodontic cement.
Dental sealants, endodontic
A substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may be intended for orthograde use, (i.e. a root filling placed from the coronal aspect).
Dental sealants, pit/fissure
A material intended for sealing pits and fissures on teeth. It may include accessories to complete the sealing procedure.
Dental shaded pontic kit
A kit/pack that contains a collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner for aesthetic and/or therapeutic purposes during treatment to realign teeth.
Dental solution, scaling
A substance used to soften and partially solubilise dental calculus (a hard deposit that forms on the teeth) before scaling mechanically so that less force is required, especially when teeth are loose.
Denture base resins
A material used for the fabrication of a denture base or repair of a denture.
Denture clasps
Dental devices designed to retain and stabilise removable partial dentures to stationary teeth.
Denture reliners
A device that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture to provide a new fitting surface for the denture.
Dental suction system cannula
A component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris and water during a dental procedure.
Facebow
A calliper-like dental instrument used to record the relative position of the maxillary arch to the temporo-mandibular joint (TMJ), or the opening axis of the jaw. It is used to orient dental casts in the same relationship to the opening axis of the articulator.
Fixture/appliance dental drill
A device intended for use in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. It is attached to a motorised hand-piece or other power source that provides rotation.
Gingiva bleaching protector
A substance designed to protect a patient's gums from the hydrogen peroxide in teeth-whitening agents used during chairside light-curing bleaching of teeth.
Gingival retraction cord, non-medicated
A non-medicated device used to temporarily hold off the gingiva during abutment preparation.
Gingival retraction kit
A kit/pack that contains collection of devices used to temporarily hold off the gingiva during abutment preparation.
Gingival retraction solution
A substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva. This device may also induce a local stasis of gingival exudates and gingival haemorrhages.
Non-medicated dental surgical procedure kit
A kit/pack that contains a collection of dental instruments, dressings and the necessary materials used to perform a dental surgical procedure. It does not contain any pharmaceuticals.
Oral wound dressing
A device intended as a protective cover for the oral mucosa to manage wounds and sores in the mouth. It is used for various types of dental wounds, sores and lesions caused by dental prostheses or orthodontic braces. It may also be used to treat mucosal irritations/inflammation, dryness and gingivitis. This does not include pharmaceuticals.
Orthodontic appliance archwire-cooling device
A device used in orthodontic dentistry to intra-orally chill or cool thermally-activated archwires when placing bends in an orthodontic appliance.
Orthodontic appliances
Dental devices designed to influence the shape and/or function of the stomatognathic system through the application of physical force.
Orthodontic space maintainer
A dental prosthetic replacement for prematurely lost deciduous teeth, intended to prevent closure of the space before eruption of the permanent successors.
Periodontal dressing
A material which is placed over the periodontal tissue as a dressing, normally after surgery. This does not include pharmaceuticals.
Root canal filling-removal solution
A substance used in endodontic procedures for the softening and removal of root canal fillings.
Root canal irrigation/ rinsing solution
A substance used to facilitate cleansing/irrigation of the root canal (the canal space) during and/or after endodontic instrumentation for the removal of the smear layer, pulpal tissue, necrotic material and bacteria from the instrumented root canal, before placement of the endodontic filling.
Root canal obturation kit
A kit/pack that contains a collection of devices designed to permanently prime, seal, and/or fill a tooth undergoing a root canal procedure.
Root canal post kit
A kit/pack that contains collection of root canal posts and devices used for the insertion of root canal posts.
Root canal posts
A device intended to be inserted and cemented into a prepared root canal of a tooth to stabilise and support a restoration.
Root canal preparation kit
A kit/pack that contains a collection of dental devices designed to be used in root canal preparation.
Root surface conditioner
A material used for topical application on exposed/scaled root surfaces for the removal of the smear layer during dental/periodontal surgery. The material is removed after the recommended period to expose the collagenous matrix of dentine surfaces.
Tooth preservation kit
A kit/pack with a collection of devices designed to preserve and transport a tooth that has been knocked out (i.e. avulsed) so it can be reimplanted. It is used to avoid tooth cell crushing and/or dehydration by immersing the tooth in a pH-balanced solution compatible with periodontal cells, and is used in field emergency situations after traumatic knocking out of teeth.
Warm-bonded endodontic obturation system
Devices designed to deliver preheated sealing, filling and core materials into a root canal for direct warm bonding during an endodontic obturation procedure.
Example
Manufacturer HSA Zen produces 3 different dental cements using different materials:
HSA Zen 1: zinc phosphate
HSA Zen 2: polycarboxylate
HSA Zen 3: glass ionomer
These cannot be grouped as a Family as they are of different materials and do not qualify as having a common design and manufacturing process.
However, they can be grouped together using DGT in one application. The devices will then be listed on the SMDR as "HSA Zen Dental Cement".
Addition of new dental device models
You can add new dental device models to an existing SMDR DGT device listing if the new models fulfil the same DGT grouping criteria.
Please submit a Change Notification to make such additions.
