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
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.