PMC:2871132 / 6712-8994 JSONTXT

{"project":"NEUROSES","denotations":[{"id":"T104","span":{"begin":52,"end":59},"obj":"PATO_0000392"},{"id":"T105","span":{"begin":470,"end":474},"obj":"CHEBI_33290"},{"id":"T106","span":{"begin":708,"end":712},"obj":"CHEBI_33290"},{"id":"T107","span":{"begin":479,"end":483},"obj":"CHEBI_23888"},{"id":"T108","span":{"begin":717,"end":721},"obj":"CHEBI_23888"},{"id":"T109","span":{"begin":765,"end":769},"obj":"CHEBI_23888"},{"id":"T110","span":{"begin":1658,"end":1662},"obj":"CHEBI_23888"},{"id":"T111","span":{"begin":960,"end":963},"obj":"CHEBI_37684"},{"id":"T112","span":{"begin":1026,"end":1033},"obj":"CHEBI_38960"},{"id":"T113","span":{"begin":1767,"end":1772},"obj":"CHEBI_24433"},{"id":"T114","span":{"begin":1867,"end":1872},"obj":"CHEBI_24433"},{"id":"T115","span":{"begin":2187,"end":2192},"obj":"CHEBI_24433"},{"id":"T116","span":{"begin":1919,"end":1930},"obj":"CHEBI_33232"}],"text":"2.1. Safety Concerns\nSafety concerns should not be limited to dental implants, but also to all dental devices. Specifications and standards have been developed to aid producers, users, and consumers in the evaluation of the safety and effectiveness of dental products. However, the decision of products to test their materials according to national and international standards is purely voluntary [10]. Until the passage in 1976 of the Medical Device Amendments to the Food and Drug Act, medical and dental materials and devices for use in the human were not regulated by any agency of the United States government. The only exception was materials for which therapeutic claims were made, which allowed the Food and Drug Administration (FDA) to consider them as a drug. The Medical Device Amendments of 1976 gave the FDA jurisdiction over all materials, devices, and instruments used in the diagnosis, cure, mitigation, treatment, or prevention of disease in man. This includes materials used professionally and the over-the-counter products sold directly to the public. The Dental Panel places an item one of three classes: Class I, materials posing minimum risk: these are subject only to good manufacturing and recordkeeping procedures. Class II, materials for which safety and efficacy needs to be demonstrated and for which performance standards are available: materials must be shown to meet the performance standard. Class III, materials that pose significant risk and materials for which performance standards have not been formulated: this class is subject to premarket approval by the FDA for safety and efficacy, in much the same manner as a new drug [11].\nAccording to ISO specifications [12], implant devices are required to evaluate several tests; for Group I tests (cytotoxicity tests: ISO 7405, 6.1 and 6.2, and cytotoxicity tests: ISO 10993.5), for Group II tests (subchronic systemic toxicity – Oral application: ISO 10993.11.6.7.1, skin irritation and intracutaneous reactivity: ISO 10993-11.5.2, and sensitization systemic toxicity–application by inhalation: ISO 10993.11.6.7.3, genotoxicity: ISO 10993.3, and local effects after implantation: ISO 10993.6), and for Group III (pulp cappling and pulpotomy: ISO 7405.6.4, and endodontic usage test: ISO 7405.6.5)."}