Microsoft word - core.it-bio ass

Biocompatibility Assessment Study, Page 1 of 13 Report of Biocompatibility
Assessment Studyof Core it
Dual
Prepared by: K.H. Beak /QA Approved by: J.H. Kim /President SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 2 of 13 1. Purpose and references 2. Device description 3. Raw material of Core it Dual 4. Quantitative formulation 5. Flow chart to aid in systematic approach to biological evaluation of Core it Dual 6. Reference test 7. Final assessment

1. Purpose and references

1.1 Purpose of study
This study is planned for the selection of biocompatibility test for Core it Dual. The purpose of this assessment is to ensure that no undue risks arise from biological hazards associated with materials of manufacture and final devices. Most of the contents are prepared by being referenced the following standards. 1) Guidance on biocompatibility assessment - The medical device agency on 1997 2) ISO 10993-1 : 2003 Biological evaluation of medical devices – Part 1 : Evaluation and testing 3) ISO 10993-4 Part 4: Selection of tests for interactions with blood 4) ISO 10993-5 Part 5: Test for in vitro cytotoxicity 5) ISO 10993-10 Part 10: Tests for irritation and delayed-type hypersensitivity 6) ISO 10993-11 Part 11: Test for systemic toxicity Core it Dual is dual-cured composite resin designed for the fabrication of all kinds of core build-ups & build-up fillings. It has the characteristics of good depth of polymerization, high compressive strength, and radiopaque. Core•it has various shades (Blue, yellow). 1) Common name : Core Build up Resin 2) Proprietry name: Core it Dual
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Biocompatibility Assessment Study, Page 3 of 13 Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1-oxo-2- propenyl)oxy)poly(oxy-1,2-ethanediyl)) (BPE-80N) Ba glass 8235(6% silane) Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1-oxo-2- propenyl)oxy)poly(oxy-1,2-ethanediyl)) (BPE-80N) Ba glass 8235(6% silane)
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Biocompatibility Assessment Study, Page 4 of 13 Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1-oxo-2- propenyl)oxy)poly(oxy-1,2-ethanediyl)) (BPE-80N) Ba glass 8235(6% silane) Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1-oxo-2- propenyl)oxy)poly(oxy-1,2-ethanediyl)) (BPE-80N) Ba glass 8235(6% silane)
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Biocompatibility Assessment Study, Page 5 of 13 4. Quantitative formulation 4.1 Composition and other materials alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1- SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 6 of 13 alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1- oxo-2-propenyl)oxy)poly(oxy-1,2-ethanediyl)) SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 7 of 13 alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1- oxo-2-propenyl)oxy)poly(oxy-1,2-ethanediyl)) SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 8 of 13 alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1- oxo-2-propenyl)oxy)poly(oxy-1,2-ethanediyl)) SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 9 of 13 dimethacrylate(UDMA) Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1-oxo-2- 2,2-(4-methylphenylimino)diethanol (2.2-(para-Tolylimino)Diethaol) dimethacrylate(UDMA) Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1- Ba glass 8235(6% silane) Silica(R972) Camphorquinone SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 10 of 13 dimethacrylate(UDMA) Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1-methylethylidene)di-4,1-phenylene)bis(omega-((2-methyl-1-oxo-2- 2,2-(4-methylphenylimino)diethanol (2.2-(para-Tolylimino)Diethaol) dimethacrylate(UDMA) Trietyleneglycol dimethacrylate(D-GMA80) alpha,alpha-((1- Ba glass 8235(6% silane) Silica(R972) Camphorquinone SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 11 of 13 SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 12 of 13 6. Categorization by ISO 10993-1 chapter 4 7. Selection of biological evaluation test 7.1 Selection guide by ISO 10993-1 Table1 and 2, chapter 6 The raw materials of Core it Dual are not new things. These are well known materials and also used in other products smilar with Core it Dual. Also there has been no evidence of harmful side effect related with 7 kinds of test methods from Therefore, Korean FDA regulation and toxicologist concluded that the required tests for Dental ① Cytotoxicity by ISO 10993-5 ② Irritation by ISO 10993-10 ③ Systemic toxicity by ISO 10993-11 ④ Sensitization by ISO 10993-10 SPIDENT CO., LTD.
Biocompatibility Assessment Study, Page 13 of 13 8. Testing and/or rationale/justification Considering the data and reports above, Core it Dual is claimed to be biologically safe. SPIDENT CO., LTD.

Source: http://www.spident.co.kr/down/coreit/Biocompatibility%20Assessment%20Report-Core.it%20Dual.pdf