License Number: Su Food and Drug Administration Medical Device Production Permit 20160061
Registration Certificate Number: National Medical Device Approval 20193171719
Medical Device Product Technical Requirements Number: National Medical Device Approval 20193171719

Enhanced Glass Ionomer Cement (Type) Product Instruction Manual

I. Scope of Application:
Primarily suitable for cavity restoration.

II. Structure and Composition:
Silicon oxide, aluminum oxide, sodium fluorosilicate, aluminum phosphate (powder)
Acrylic acid-maleic acid copolymer, water (Type I powder)

III. Product Performance:

IV. Usage Instructions:

1. It is recommended to use an agate spatula or plastic spatula on a glass slab for mixing the product.

2. Operating environment: Recommended to use at a temperature of (23±1)°C and relative humidity of (50±10)%. High temperatures will accelerate the curing process, shortening working time. If using the product in warmer conditions, it is recommended to use a cooler glass slab.

3. Recommended powder-to-liquid ratio: 100g:0.40g (1 small spoon/drop); Test powder-to-liquid ratio: 1.00g:0.40g (1 small spoon/drop). The product should be tested under conditions of (23±1)°C and (50±10)% relative humidity.

4. Powder and liquid mixing rate:

   • When mixing, first stir the powder in the bottle, then use a small spoon to scoop the powder to the brim and level it with a spatula. Pour the powder onto the mixing pad.

   • Hold the liquid bottle vertically, with the nozzle 5mm above the mixing pad, and slowly squeeze out two drops of liquid. If bubbles appear, gently tap the bottle to allow the bubbles to rise and leave the nozzle.

   • Divide the measured powder into three equal parts. Add the first part to the liquid and mix within 10 seconds. Add the second part and mix within 15 seconds. Finally, add the third part and mix thoroughly to ensure uniform consistency.

   • Total mixing time should be completed within 60 seconds.

   • Working time: From the start of mixing, should be controlled within 90 seconds.

   • Net curing time: 1.5~6 minutes.

5. Before use, the tooth surface, base, and orthodontic attachments must be surface-treated, cleaned, disinfected, and dried. Avoid recontamination with saliva.

6. In deep cavities, cover the dentin closest to the pulp with zinc oxide eugenol cement to avoid acidic irritation.

7. Post-treatment: Immediately remove excess material with a wet cotton ball after filling. After 24 hours of curing, use grinding discs or strips for finishing, followed by polishing discs or cups for polishing. Grinding time and methods should follow standard procedures.

8. Store in a dry place at 10~23°C for optimal performance.

V. Model Specification: Type I

VI. Packaging Specifications:

Note:
1: Ivory White
2: Light Ivory
3: Ivory
Each box includes: One small spoon, one mixing pad.

VII. Storage Conditions:
Long-term storage at high temperature and humidity will shorten the product's shelf life and affect its performance.

VIII. Shelf Life:
One year. Production date is indicated on the packaging.

IX. Precautions and Notes:

1. It is recommended not to use metal spatulas to avoid discoloration of the cement.

2. After use, immediately tighten the bottle cap, as moisture adversely affects the properties of the cement.

3. The liquid may turn light yellow due to storage conditions, but this does not affect product performance and it can still be used.

X. Warnings:

1. Avoid contact with eyes. In case of eye contact, rinse immediately with plenty of water and seek medical attention.

2. Keep out of reach of children.

3. The powder and liquid provided with this product should not be mixed with those from other brands.

Company Name: Changshu Shangchi Dental Materials Co., Ltd.
Address: No. 15 Wenhua Center Road, Changqiao Village, Wentang Town, Changshu City
Production Address: No. 15 Wenhua Center Road, Changqiao Village, Wentang Town, Changshu City
Contact: 0512-52551437
Postal Code: 215531
Revision Date: November 2021