Name |
Type of Registration |
Absorbable dressing |
Extension |
Absorbable bone fixation system |
Extension |
Dental handpiece |
Initial registration |
Turbine handpiece |
Initial registration |
Disposable medical rubber examination gloves |
Class I registration |
Composite |
Extension |
Filling instrument |
Extension |
Light-curing composite |
Extension |
Soft denture liner |
Extension |
Resuscitator bag |
Extension |
Absorbable heart membrane repairing materials |
Initial registration |
Trabecular metal implant |
Initial registration |
Dental flexible crown and bridge materials |
Initial registration |
Abrasives |
Initial registration |
Articulating papers |
Initial registration |
Articulating test agent |
Initial registration |
Forceps |
Initial registration |
Fleximeter |
Initial registration |
Alginate impression material |
Initial registration |
Silicone impression material |
Initial registration |
Bonding agent |
Initial registration |
Etching gel |
Initial registration |
Addition type silicone impression material |
Extension |
Impression material for lab use |
Extension |
Note:
1. Class I registration: registration for class I medical devices, with permanent validity.
2. Initial registration: registration for class II and III medical devices, valid for 5 years.
3. Extension: 5 year extension of existing registration certificate for class II and III medical devices.