DAIYAMONDO

Daiyamondo Diamond Polishing Paste

Dental Polishing Paste with Diamond Powder

General Information

Kagayaki® Daiyamondo is a diamond-filled dental polishing paste supplied in a syringe, intended for use in dental departments of clinics, hospitals, polyclinics, and dental offices, in the fields of restorative, prosthodontic, and dental laboratory practice.

The paste is used to give a mirror-like shine to restorations made of composites, ceramics, and glass ionomers.

Daiyamondo is recommended for use together with a felt/wool polishing wheel or a goat-bristle brush.

Intended Purpose and Indications for Use

Kagayaki® Daiyamondo is intended to give smoothness and a bright shine to restorations made of composites, ceramics, and glass ionomers.

The product is intended to be used by dental professionals only, in accordance with applicable occupational safety regulations and these instructions for use.

Composition

Humectant.
Diamond powder (particle size 0.1–1 µm).
Solubiliser.
Thickener.
Flavouring agent.
Preservative.
Colorant.

Contraindications and Possible Side Effects

Do not use the product if the patient is known to be allergic or hypersensitive to any of the listed ingredients.

No adverse reactions are expected when the product is used as intended and in accordance with these instructions for use.

Possible risks associated with improper use include irritation of the skin, eyes, or oral mucosa from contact with the paste, and overheating of the treated surface if the paste is not kept on the polishing tool throughout treatment.

Warnings and Precautions

For professional dental use only.
Use in accordance with applicable occupational health and safety regulations and these instructions for use.
Protective eyewear must be worn when using the product.
Do not use the product after the expiry date indicated on the packaging.
Do not use the product if the packaging or syringe is damaged.
Keep the paste present on the polishing tool throughout the polishing process to avoid overheating of the treated surface.
Do not exceed the rotational speed recommended in the instructions for use of the polishing tool; excessive speed may cause overheating of the treated surface or splashing of the paste.
Avoid contact of the paste with skin and eyes.
Close the syringe cap tightly immediately after each use to prevent contamination and drying out of the paste.
Keep the product away from heat and direct sunlight.
Seek medical attention in the event of eye, skin, or oral mucosa irritation, or in case of accidental ingestion.

Instructions for Use

Check that the packaging and syringe are undamaged before use.
Open the package.
Remove the cap from the syringe.
Dispense a small amount of paste (approximately 3 mm) onto the polishing tool (felt/wool wheel or goat-bristle brush).
Close the syringe cap tightly immediately after dispensing.
Spread the paste in a thin layer over the surface to be treated.
Polish the surface in accordance with the instructions for use of the polishing tool.
Do not exceed the rotational speed recommended in the instructions for use of the polishing tool, to avoid overheating of the treated surface or splashing of the paste.
For best polishing results, the treated surface may be moistened with water.
Rinse off the paste with water after use.

Storage, Transport and Shelf Life

Store the product in closed premises at air temperature from +5 °C to +25 °C, with relative air humidity not more than 80%, in places protected from dirt, chemicals, heat, and possible mechanical damage. Keep away from direct sunlight.

The medical device may be shipped by any mode of covered transport in accordance with the shipment rules for the relevant transport mode.

Poor storage conditions can reduce shelf life and damage the product.

Warranty shelf life: 2 years.

The manufacture date, expiry date, LOT number, and article number are indicated on the product packaging (label).

Disposal

After use, dispose of the syringe and any packaging in accordance with local legislation and the dental facility’s procedures for used dental materials.

Package Contents

Daiyamondo paste — 1 pc. (1 g syringe).

Reporting serious incidents

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established. Enquiries about a suspected serious incident can also be sent to support@kagayaki.eu.

Manufacturer and EU Authorised Representative

Manufacturer: Shenzhen Kagayaki Technology Co., Ltd., 301, Building 1, Zhenyu 2nd Road, Fifth Industrial Zone, Yulu Community, Yutang Subdistrict, Guangming District, Shenzhen, China. EUDAMED Single Registration Number (SRN): CN-MF-000050831.

EU Authorised Representative: Aleksandra Bashinskaia, Urbanização Crastos, Lote 43, 8400-450, Porches, Portugal. EUDAMED Single Registration Number (SRN): PT-AR-000050489. Phone: +351 926605123. Email: ra.pt@kagayakipolish.com.

For general enquiries or to submit a complaint, contact support@kagayaki.eu.