Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit. Final order.

The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).

Dental Devices; Reclassification of Electrical Salivary Stimulator System. Final order.

The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the "electrical salivary stimulator system." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Verificação dos equipamentos radiográficos odontológicos quanto às normas de proteção radiológica / Verification of dental X-Ray machine according to the radiological protection norms

O objetivo com este estudo foi avaliar a adequação de equipamentos de raio X, usados para realização de radiografias intrabucais, quanto às normas de proteção radiológica por meio da verificação do sistema de colimação, do uso de sistema de alinhamento e posicionamento do filme, da distância foco-extremidade de saída do localizador, do kVp nominal e do formato e comprimento do localizador. Com relação aos tamanhos de campo preconizados na portaria 453 apenas 38 por cento dos equipamentos estavam em conformidade com os valores exigidos e 32 por cento apresentaram-se de acordo com os valores aceitos. Porém, destes 32 por cento, uma porcentagem de 16 por cento não utilizava sistema de alinhamento e posicionamento de filme, portanto, estavam em desarcordo com os preceitos da portaria...

Dental devices; dental noble metal alloys and dental base metal alloys; designation of special controls. Final rule.

The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.

Medical devices: classification of the dental sonography device and jaw tracking device. Final rule.

The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Dental products devices; reclassification of endosseous dental implant accessories. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is reclassifying the manually powered drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, trial abutments, and other manually powered endosseous dental implant accessories from class III to class I. These devices are intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than an hour. FDA is also exempting these devices from premarket notification. This reclassification is on the Secretary of Health and Human Services' own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Realizaçäo da técnica do paralelismo utilizando posicionadores e cilindro curto: suas conseqüências / Execution of the paralleling technique using positioner and short cylinder: its consequences

Devido ao grande número de profissionais que passaram a utilizar a técnica do paralelismo em suas clínicas odontológicas com o auxílio de posicionadores e a näo substituiçäo do cilindro curto pelo cilindro longo, sendo, muitas vezes, essas radiografias usadas para realizaçäo de mensuraçöes, foi realizado este estudo com o objetivo de se conhecer qual seria o aumento da área irradiada na face do paciente e qual o benefício que se pode obter em relaçäo ao tamanho da imagem do objeto radiografado. Podemos concluir que, ao realizarmos a técnica do paralelismo com distância foco-filme de 40 cm, porém, sem a substituiçäo do cilindro localizador curto pelo longo diafragma de menor diâmetro, estamos aumentando a área irradiada em mais de 470 por cento do valor permitido por lei. O aumento da imagem do objeto a uma distância foco-filme de 20 cm é de 12,5 por cento, e é reduzido para 3 por cento quando utilizada a distância foco-filme de 40 cm

Does one articulator meet the needs of both fixed and removable prosthodontics?

A survey to determine the type of articulators used in teaching fixed and removable prosthodontics in the 59 United States dental schools was conducted. Of 115 questionnaires mailed, 104 responses were received. The following observations resulted from analysis of the questionnaire. Of the 81 articulators used in fixed and removable prosthodontics, 65 (76.5%) were of the arcon design. The most common articulators used were the Whip-Mix (16 schools), the Hanau 158 (14 schools), the Hanau 96 H-2 (13 schools), and the Denar Mark II (11 schools). The most common articulators used in fixed prosthodontic programs were the Whip-Mix (16) and the Denar Mark II (11), while the most common articulators for removable prosthodontics were the Hanau 158 (14) and the Hanau 96 H-2 (13). Twenty-two schools issued two articulators of different design, and three schools issued two articulators of the same design. The outstanding difference in requirements for fixed and removable prosthodontic teaching programs was that those in fixed prosthodontics desired an articulator in which the maxillary and mandibular members could be separated, while those in removable prosthodontics did not.