치주 및 임플란트 치료에서의 조직공학적 전략 Tissue engineering strategies in periodontology and dental implantology

조 영 단

cacodm1@snu.ac.kr

서울대학교 치의학대학원 치주과학교실

Periodontal disease is a major public health issue and the development of effective therapies to treat the disease and regenerate periodontal tissue is an important goal of today's medicine. In the case of tooth extraction due to poor prognosis, dental implant is one of treatment modalities. The way to accelerate bone regeneration and reduce the healing time for functional restoration after implant placement has been a challenge for dental clinicians. Tissue engineering of alveolar bone surrounding teeth or dental implants is achieving the targeted and sustained delivery of growth factors. In this study, we combined the use of CVD technology and BMP gene delivery on titanium for the promotion of bone regeneration and bone to implant contact in vivo. And we developed a regenerative scaffold that improves bone regeneration through tissue-specific delivery of BMPs through nanoparticles.

학력

서울대학교 치의학대학원 졸업

서울대학교 치의학 석사, 박사

경력

서울대학교치과병원 인턴, 레지던트, 전임의, 진료교수 (치주과)

University of Michigan School of Dentistry 오스테올로지 재단 연구장학생, 외래교수

(현) 서울대학교 치의학대학원 치주과학교실 조교수

학회 및 전문가 활동

대한치주과학회 학술실행이사

대한구강악안면임프란트학회 학술실행이사

한국생체재료학회 치의학분야 학술위원

공직치과의사회 보험연구이사

중점연구분야

1. Epigenetics

2. Periodontal tissue regeneration

3. Implant surface modification

4. Clinical periodontology and implantology

치과의료기기 및 치과생체재료의 2017/745 MDR 유럽인증 동향 European Market Approval Trend of Nonactive Dental Device/Biomaterials under New EU 2017/745 MEDICAL DEVICE REGULATION

엄 수 혁

soo.hyuk.uhm@dnv.com

DNV

The application date of 2017/745 MDR is 26 May 2021, when it will officially supersede the 93/42/EC Medical Device Directive (MDD) that came into effect in 1993. Medical device companies that market their products in the EU are now responsible for meeting new, comprehensive requirements and compliance expectations during the entire lifecycle of their products. Every medical device manufacturer, importer, and distributor who wants to continue marketing their product into the EU or initiate business in the EU after 26 May 2021 will be responsible for MDR compliance. This is a significant change for many different organizations around the world. The rigor required by EU notified bodies will affect the time and resources companies need to become MDR compliant based on the risk of the device.

The purpose of this presentation is to highlight new facets of EU Medical Device Regulation (MDR) in the medical device industry related biomaterials. The presentation contains references to both MDR legal articles and recommendations that will challenge organizations to take a more holistic viewpoint of their products, resources, and regulatory toolkit to be compliant in the EU.

학력

2010 신한대학교 보건대학 치의기공학과 보건학사 졸

2014 연세대학교 치과대학 응용생명과학과(치과생체재료학) 치의학 박사 졸

경력

2010-2014 연세대학교 치과대학 치과생체재료공학교실 연구원

2014-2016 연세대학교 치과대학 치과생체재료공학연구소 박사후연구원

2016-2019 DNV Korea MDR 의료기기 유럽인증 심사원 (Technical Assessor)

2019-현재, DNV Norway 의료기기 유럽인증 심사원 (Certifier)

학회 및 전문가 활동

대학치과재료학회 산업이사

한국치과의료기기부작용 인과관계조사관 (의료기기법 제 43조)

ISO TC 194 Biocompatibility 전문위원 (WG1 ISO10993-1, WG4 ISO14155)

중점연구분야

1. 치과용/정형외과용 경조직 재생을 위한 유무기 재료연구 (2010-2016)

2. 체내 조직과 재료의 상호작용 강화를 위한 치과/정형외과 생체재료 표면개질 기술 (2010-2016)

3. 생체활성, 생체흡수, 나노재료, 동물유래물질 의료기기 유럽인증 (2016-2022)