FDA QSR UPDATE – ISO 13485 Alligned QMSR Final Rule Getting Closer

By Eric Thorn, Esq Beginning back in the spring of 2018, FDA announced its intent to adopt rules to replace the current quality system regulations (QSR) found in 21 CFR Part 820 with rules more aligned with International Organization for Standardization (“ISO”) standard ISO 13485:2016 (ISO 13485). This year, on February 23, 2022, FDA published…

The Effect of Smoking on Your Teeth, Gums & Oral Health

How Does Smoking Affect Your Oral Health? People who smoke are at risk for oral health problems. Cigarettes and tobacco can cause gum disease, oral cancer, and tooth loss.1 They also have a higher risk for complications following mouth surgery and tooth removal. Smoking affects your teeth and other structures in the mouth. The most common oral…

Celebrating Skill, Reliability, and Adaptability: Dental Technician and CDT Appreciation Month

NBC, NADL, and FDLT are extremely pleased to dedicate the month of June to the appreciation of dental technicians and Certified Dental Technicians (CDTs). Dental technicians and CDTs develop specialized skills in order to provide care to patients in need. The reliability of that care is fortified by dedication to standards of excellence and continuing…

Mapping a New Course to Shade Determination

Introduction Although many aspects of dentistry have seen massive improvements in technology, process, and efficiency, shade communication and determination have been largely unchanged. The introduction of Mobile Dental Photography has not only expedited a technical jump, but has also opened the door to stark process improvements. Accelerated by a pandemic and the near extinction of…

FDA 510(k) Clearance – An Overview

By Eric Thorn, Esq. Well to start off with, no a 510(k) is not some type of retirement plan, that’s a 401(k).  Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug Administration (FDA) with at least 90-day advance notice of…

Fact or Fiction: DOL Classification of Dental Laboratory Technicians

By NADL Executive Director Bennett Napier, CAE This general timeline of activities, covering key moments in the last ten years, is intended to provide clarity on the classification system of occupations used by the U.S. Department of Labor (DOL), including dental laboratory technicians. For background, the O*Net system classifies occupations based on the following criteria:…

Scannability of Soft Tissue Casts

INTRODUCTION Making the emergence profile around implants cleansable is a highly desirable characteristic for a successful implant restoration. With an increased demand for esthetic implant restorations, especially in the anterior, effective management of the soft tissue and the emergence profile is critical. In addition to being esthetic, proper contouring of the peri-implant soft tissue helps…

All-Ceramic Single-Tooth Restorations for Treating Damaged Dental Enamel

Long-term results in patients with and without amelogenesis imperfect Teeth that have been affected by extensive wear or a genetic disorder can be successfully restored with adhesively bonded all-ceramic restorations. The following article summarizes the outcomes of a series of complex clinical cases. Two different groups of patients require the rehabilitation of impaired full dentitions:…

The Industrial Revolution

Klaus Schwab, economist and Founder and Executive Chairman of the World Economic Forum, the International Organization for Public-Private Cooperation, authored a best-selling book entitled, The Fourth Industrial Revolution. In it, he explains that the fourth revolution is different from any previous revolution in scale, scope and complexity. This technological revolution impacts all economies, governments and…