March 22, 2018
The number of stomatology material samples for biocompatibility studies
In one of previous articles we discuss quantity of medical device samples for toxicological testing (biocompatibility trials). Current article is about necessary number of stomatology (dental) material samples for toxicological testing.
The standard regulated this quantity in Russia is GOST 31576. And its actual version is GOST 31576-2012. The 3rd section of these standards contain the table, regulating the necessary number of samples:
| Name of medical devices and materials | Minimal necessary number of samples must contain ... of substance |
| 1. Materials for restoration of anatomic shapes and functions of teeth. | |
| 1.1. Polymeric materials for restoration. | |
| 1.1.1. Composite materials for chemical and UV induration. | 120 mg |
| 1.1.2. Self-polymerizing materials (non-prefilled polymers). | 60 mg |
| 1.2. Compomers and glass-ionomeric materials. | 100 mg |
| 1.3. Mineral cements (silicate, phosphate, for children's practic, bactericidal). | 100 mg |
| 1.4. Amalgams (silver, copper, with big- and small quantity of copper, Gallium-based). | 300 mg |
| 2. Materials for layings, fixing of nonremovable prosthesises, temporary and medicinal bandages. | |
| 2.1. Phosphate, bacterycidal, silicophpsphate, copper-containing etc. cements. | 50 mg |
| 2.2. Polycarboxilate, synthetic resins-based, glass-ionomeric cements. | 50 mg |
| 2.3. Materials with calcium hydroxide (suspensions, gels, solid pastes). | 50 mg |
| 2.4. UV indurable compositions. | 50 mg |
| 2.5. Zincum oxide eugenol materials. | 50 mg |
| 2.6. Zincumsulphate materials (dentine paste, water dentine). | 50 mg |
| 2.7. UV-indurable materials for layings. | 50 mg |
| 3. Devices and systems for cavities preparation for filling with composite materials. | |
| 3.1. Primers and adhesives. | 0.3 mg |
| 3.2. Devices for protection of teeth and fillings surface | 0.3 mg |
| 3.3. Devices for conditioning and preetching of enamel and dentine. | 0.1 cm2 |
| 4. Endodental materials. | |
| 4.1. Materials for medicinal processes of canals (desinfection, bouging, hemostasis, degreasing, drying) | 2 mg |
| 4.2. Materials for filling of canals (plastic nondurable, plastic indurable pastes, systems "powder-liquid" and "paste-paste"). | 2 mg |
| 4.3. Dowels. | |
| 4.3.1. Silver. | 1 item |
| 4.3.2. Gutta-percha and thermophilic. | 1 item |
| 4.3.3. Paper. | 1 item |
| 5. Substances for pulp devitalisation. | |
| 5.1. Containing arsenic. | 0.2 mg |
| 5.2. Not containing arsenic. | 0.2 mg |
| 6. Substances for prophylaxis of caries and stamatological deseas. | |
| 6.1. Fluorine containing preparations (gels, suspensions, lacquers etc.). | 3 mg |
| 6.2. Sealants for fissures. | 3 mg |
| 6.3. Fluorine free pastes for teeth cleaning and removing of dental scurfs. | 3 mg |
| 6.4. Liquids and pastes for dental scurs dilution. | 3 mg |
| 6.5. Substances for teeth whitening. | 3 mg |
| 7. Materials for orthopaedic stomatology | |
| 7.1. Materials for production and repairing basises of removable prosthesises of hot and cold polimerisation. | 30 mg |
| 7.2. Materials for production of dental crowns and bridge-shaped prosthesises. | 20 mg |
| 7.3. Artificial teeth. | 20 mg |
| 7.4. Materials for soft and elastic supports of removable dental prosthesises. | 30 mg |
| 7.5. Materials for temporary bridge-shaped dental prosthesises. | 30 mg |
| 8. Stomatological alloys and devises of theese alloys. | |
| 8.1. Noble metal based. | 40 mg |
| 8.2. Non-noble metal based. | 20 mg |
| 9. Porcelain masses. | |
| 9.1. Porcelain masses (ceramic, glass-ceramic). | 45 mg |
| 9.2. Porcelain teeth. | 45 mg |
| 9.3. Tinctures for ceramic prosthesises. | 0.5 mg |
| 10. Moulding materials. | |
| 10.1. Solid moulding materials. | |
| 10.1.1. Plasters. | 50 mg |
| 10.1.2. Zincum oxide eugenol materials. | 50 mg |
| 10.1.3. Thermoplastic moulding materials. | 50 mg |
| 10.2. Elastic moulding materials. | |
| 10.2.1. Alginate moulding materials. | 50 mg |
| 10.2.2. Silicate materials. | 50 mg |
| 10.2.3. Polysulfide moulding materials. | 50 mg |
| 10.2.4. Polyetheric materials. | 50 mg |
| 10.3.Hydrocolloid moulding materials | 50 mg |
| 11. Auxiliary materials. | |
| 11.1. Moulding materials. | |
| 11.1.1. Based on plaster (cast). | 0.1 cm2 |
| 11.2. Dental waxes. | 0.1 cm2 |
| 11.3. Lacquers and insulating materials. | 0.1 cm2 |
| 11.4. Low-melting alloy. | 0.1 cm2 |
| 12. Materials for surgical stomatology. | |
| 12.1. Implantable materials for facial reconstructive surgery. | max dose/500 ml |
| 12.2. Endosteal and subperiosteal implants. | max dose/500 ml |
| 12.3. Materials, stimulating reparative processes in paradontium (osteoplastic). | |
| 12.3.1. Collagen-based. | 10 mg |
| 12.3.2. Hydroxyapatite-based. | 30 mg |
| 12.4. Needles. | 1 item |
| 12.5. Suture material. | 0.4 cm |
| 13. Preparations for paradontal manipulations. | |
| 13.1. Paradontal bandages and compresses. | 1.6 cm2 |
| 13.2. Bone substitute for paradontal pockets. | 30 mg |
| 13.3. Paradontal films. | 1.6 cm2 |
| 14. Equipment for processes with stomatological materials. | |
| 14.1. Tools for preparation of hard dental tissues. | 1 item |
| 14.2. Tools for processing and bouging of canals. | 1 item |
| 14.3. General purpose tools for stomatological office, (therapeutic, surgical and orthopaedic). | 1 item |
| 14.4. Rotating surgical tools (bone milling cutters, surgical dental drills). | 1 item |
| 15. Auxiliary devices for stomatological office. | |
| 15.1. Separation plates, fascias, interdental wedges. | 1 item |
| 15.2. Retraction threads. | 0.4 cm |
| 15.3. Hygroscopic tampons, rollers, pelettas etc. | 1 item |
| 15.4. Spit aspirators. | 1 item |
| 15.5. Devices of gauze. | 1.6 cm2 |
| 15.6. Professional clothes. | 1 cm2 |
| 15.7. Copying paper. | 0.1 cm2 |
We hope, that this information will help you during the registration process of dental medical device.
