YY/T 0520-2009Titanium and titanium alloy dental implant attachments (English PDF)

3.5 Central screw

A screw that penetrates the center of the abutment AND fastens the abutment onto the implant.

3.6 Cover screw, healing screw, closure screw

After the implant is implanted in the jaw, the cap structure above the implant is screwed in to avoid tissue growth. During secondary operation, the cover screw is taken out, AND the abutment is installed in place.

3.7 Healing cap/hygiene screw, hygiene cover screw, hygiene cap

Attachments which are temporarily installed onto the abutment end.

3.8 Healing abutment

A transitional abutment. In the soft tissue healing period after surgery, the healing abutment is attached to the implant, which helps the soft tissue to be shaped in accordance with the shape of the healing abutment AND then replaced by the abutment.

5.1 Appearance

the tweezers to take all the implant attachments out from the beaker; USE the qualitative filter paper to filter the liquid in the beaker; AND there shall be no visible attachment on the filter paper.

6.7 Fatigue limits

MAKE test in accordance with YY/T 0521-2009, AND the test results shall comply with the provisions of clause 5.7.

6.8 Chemical composition

MAKE test in accordance with GB/T 4698-1996, AND the chemical composition shall comply with the provisions of clause 5.8.

6.9 Sterile

MAKE test in accordance with the Appendix XI H "Sterile test method" of the Pharmacopoeia of the People's Republic of China (Volume II), AND the test results shall comply with the provisions of clause 5.9.

6.10 Pyrogen

MAKE test in accordance with the Appendix XI H "Pyrogen test method" of the Pharmacopoeia of the People's Republic of China (Volume II), AND the test results shall comply with the provisions of clause 5.10.

7.1 Product marking

If the size and surface conditions of the dental implant attachment permit, under the preconditions of not affecting the use performance of the dental implant attachment, it shall make clear manufacturer marking, product batch (serial) number, and specification marking on an appropriate region at each dental implant attachment surface. However, if the size and surface conditions do not permit, it shall use the label or other methods to provide the information required, in order to ensure the traceability.

7.2 Labeling and packaging mark

The labeling and packaging mark of dental implant attachment shall include at least the following.

a) Product name, model, specification;

b) Manufacturer's name, address, and contact information; […]