• Journal of the Korean Society of Safety
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• v.27 no.2
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• pp.92-97
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• 2012

Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.

• Archives of Plastic Surgery
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• v.47 no.3
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• pp.235-241
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• 2020

Background This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data. Methods This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant. Results At patients' 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases. Conclusions The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.

• The Journal of the Korea institute of electronic communication sciences
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• v.14 no.3
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• pp.619-626
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• 2019

The advances of semiconductor and circuitry technology dovetailed with nano processing techniques have further enhanced micro-miniaturization, sensitivity, longevity and reliability in MID(Medical Implant Device). Nevertheless, one of the remaining challenges is whether power can sufficiently and continuously be supplied for the operation of the MID. Self-powered MID that harvest biomechanical energy from human motion, respiratory and muscle movement are part of a paradigm shift. In this paper, we developed a rechargeable pacemaker through self-power generation with the triboelectric nanogenerator. We demonstrate a fully implanted pacemaker based on an implantable triboelectric nanogenerator, which act as a storage as well as active movement on a large-animal(dog) scale. The self-power pacemaker harvested from animal motion is 2.47V, which is higher than the required pacemaker device sensing voltage(1.35V).

• Management & Information Systems Review
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• v.36 no.1
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• pp.181-213
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• 2017

According to the aging, the medical device industry is focused as a future promising industry. However, Korea medical device industry is not enough market competitiveness due to a narrow domestic market and a small company structure. This study aims at evaluating medical device priorities following 3 steps. First, we classify the medical device into three hierarchy categories and AHP survey was conducted on 30 experts in order to extract medical device priorities. Second, priority scores of medical device are analysed using AHP and Fuzzy-AHP. Third, a most important medical device is selected by comparing the volume of medical device manufacture and priority scores. As a result, 'dental implant' is the most import medical device, and we suggest a strategy based on a positioning map. The proposed methodology will provide a inspiration for establish of R&D and support policy in the medical device industry.

• Proceedings of the Korean Institute of Surface Engineering Conference
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• 2016.11a
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• pp.117-117
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• 2016

Total ankle replacement (TAR) is a visible option in the surgical treatment of degenerative or inflammatory diseases of ankle joint. it is attributed to the current TAR which has improvements in surgical technique, uncemented implant fixation and minimally constrained articulation. In the clinical result, they can show promised surgical result when compared to earlier attempts in TAR. However, TAR is still not as successful as total knee replacement (TKR) or total hip replacement (THR), it needs to be note that there are limitations in concerning of long term performance of TAR, the high failure rate still associated with wear of the PE (polyethylene) component that has related with their material property and surface roughness. The aim of this study was to introduce the tribology characteristics of total ankle joint prosthesis with one of TDR model which was fabricated to try multi-axis wear test as a region of motion in ankle joint. The wear specimen of TDR was prepared with Ti-6Al-4V alloy and UHMWPE (ultra-high molecular weight polyethylene) for tibia-talus and bearing component, respectively. A wear test was carried out using a Force 5 (AMTI, Massachusetts, US) wear simulator which can be allowed to move in three axis to flexion-extension ($+3^{\circ}{\sim}-6^{\circ}$), internal-external axial rotation (${\pm}5^{\circ}$), as well as sinusoidal compressive load (1.6 kN, R=10). All tests were performed following standard ISO 14243, wear rate was calculated with weight loss of UHMWPE bearing while the specimen has tested at certain cycles. As based on the preliminary results, wear rate of UHMWPE bearing was $7.9{\times}10^{-6}mg/cycles$ ($R^2=0.86$), calculated loss weight until $10^7cycles$ was 79 mg, respectively.

• Archives of Craniofacial Surgery
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• v.20 no.5
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• pp.319-323
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• 2019

Cochlear implant extrusion, which is a common complication of cochlear implants, is generally repaired by a well visualized soft-tissue flap. A 61-year-old female patient with a medical history of schizophrenia who had a skin ulcer that caused cochlear implant extrusion, but that would be a stronger statement was referred to our department for removal of the implant and reconstruction of the resultant scalp defect. Accordingly, the broad defect was covered via rotation of a temporoparietal fascia flap (TPFF) using the superficial temporal artery, with the pedicle in the preauricular region as the pivot point. Coverage of TPFF was achieved with a split-thickness skin graft using the scalp as the donor site, which led to a quick recovery after the operation and satisfactory results in terms of aesthetics. This case suggests that a TPFF might be used as a flexible flap with low donor site morbidity for reconstructing cases of cochlear implant extrusion accompanied by a large full-layer scalp defect.

• The Journal of Advanced Prosthodontics
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• v.7 no.1
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• pp.62-68
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• 2015

PURPOSE. The purpose of this research was to evaluate the amount of reosseointegration after counter torquing (reverse torque) and transposing the installed implants at different times. MATERIALS AND METHODS. This study was done on ten tibiae of five cross-bred dogs. At the first day one implant was installed in each tibia. After one week half of the implants were randomly counter torqued (1WCT) and the other half were explanted and reimplanted in a new juxtaposition site (transposed)(1WT). At the same time three new implants were installed in each dog, one of them was considered as one week control (1WC) and remaining two as 8 week groups (8WCT&8WT). After eight weeks the 1WCT and 1WT implants were loosened by counter torque and the quantity of needed force for liberation was measured with the digital device (BGI). At the same time one implant was installed in each dog as eight week control (8WC) and the same protocol was repeated for 8 week groups after another 8 weeks. RESULTS. All implants were osseointegrated. Mean quantities of osseointegration in case groups indicated better amounts rather than control groups. CONCLUSION. Counter torque or transposition of the installed implants one week or eight weeks after the implantation did lead to osseointegration.

• Journal of Periodontal and Implant Science
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• v.28 no.4
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• pp.809-822
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• 1998

Adequate root preparation in the treatment of periodontal disease often involves mechanical instrumentation to remove plaque, calculus perhaps contaminated cementum. Although meticulous scaling and root planing may remove some cementum, the use of aggressive root planing to remove cementum does not appear warranted. So ultrasonic device and rotary instrument appear to be replacing hand instrument. But it is not clear those instruments make smooth root surface as hand instrument. The roghness of the root surface were evaluate with SEM following instrumentation with Gracey curette, Perio Clean and piezo ultrasonic device(Setlec) with various tip. 20 extracted teeth were used in vitro experiment, and 9 teeth of a patient destined for extraction for periodontal reasons were utilized in vivo experiment. It was demonstrated that hand curette created the smoothest surface, while diamond tip tended to roughen the root surface. But the hand curette, Perio Clean, and piezo ultasonic device with scaler tip tend to remove cementum completely. Piezo ultrasonic device with curette-like tip made the desirable smooth surface with partial removal of cementum.

• Journal of Periodontal and Implant Science
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• v.51 no.1
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• pp.30-39
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• 2021

Purpose: The present study was undertaken to examine whether periodontal probe visibility (PV) accurately reflects gingival thickness (GT) and to identify factors affecting PV using cluster and multivariate analyses. Methods: The clinical characteristics of the maxillary central incisors (n=90 subjects) were examined. Clinical photographs, sex, PV, probing depth, gingival width, papilla height, GT as measured with an ultrasonic device, and the ratio of crown width to crown length were recorded. Multivariate analysis, using multinomial baseline-category logistic regression, was used to identify factors predictive of PV. Cluster analysis was used to identify gingival biotypes. Results: In the multivariate analysis, sex was the only significant predictor of PV (odds ratio, 6.48). Two clusters of subjects were created based on morphometric parameters. The mean GT among cluster A subjects was significantly lower than that among cluster B subjects (P=0.015). No significant difference was found between cluster A and B subjects in terms of PV score (P=0.583). Conclusions: Periodontal PV was not associated with GT as measured directly using an ultrasonic device. Sex was a highly significant predictor of periodontal PV. GT was found to be correlated with morphological characteristics of the periodontium.

• Journal of Periodontal and Implant Science
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• v.28 no.4
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• pp.823-828
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• 1998

A primary goal of periodontal therapy is the creation of root surfaces that are free of plaque and calculus. It is not yet to be determined whether it is desirable to have a smooth root surface after treatment. It is also not clear what degree of roughness result from different instruments. In the present study various instruments for root surface debridement were evaluated. 20 extracted teeth were utilized, and the teeth were treated with one of the following instrument: Gracey curette, Perio Clean, and piezo ultrasonic device(Setlec, P Max) with general scaler tip, curette-like tip, and diamond tip. 3 dimensional planimetric device(Accura) was used to evaluate the average surface roughness. It was demonstrated hand and power-driven instruments did not have a significant difference in roughness of the root surface following instrumentation. And ultrasonic scaler tip tended to make a most smooth surface than other instruments. The possible reasons of the result were discussed.