Journal of Oral Implantology October 2013 - (Page 523)

LETTER TO THE EDITOR Food and Drug Administration: Reclassification of Blade Form Dental Implants Dear Editor, On July 18, 2013, Dr Ralph Roberts and I testified before the U.S. Food and Drug Administration’s Dental Products Panel of the Medical Devices Committee, Docket No. FDA-2012-N-0677, Blade Form Endosseous Dental Implants. The panel acted responsibly and elected to reclassify blade form endosseous dental implants from a Class III to Class II medical device. Blade forms are now in the same classification as root form dental implants. This is significant because there have been several past attempts to reclassify blade form implants over the last 2-1/2 decades. The panel was composed of numerous dental and medical academics, representatives from the medical device industry, and patient and consumer interest groups. The significance of this reclassification impacts the manufactures in a positive manner. Class III devices, which are considered high risk, require general and special controls and a premarket approval (PMA). The PMA is a considerable financial burden of several million dollars to the manufactures of medical devices. Class II status, for a medium risk device, requires the rigorous 510(k) application process, and associated fees of approximately $100 000.00, exclusive of any clinical trials and without the financially burdensome PMA. The panel extensively deliberated on the safety, training, and efficacy of blade form dental implants. Dr Roberts, the coinventor of blade form dental implants, discussed the history of the development of blade forms and presented his cases with over 43 years of absolute successful service in atrophic bone. Drs Ralph and Harold Roberts, coinventors of the blade form and ramus frame dental implant, collaborated for many years, * Corresponding author, e-mail: DOI: 10.1563/AAID-JOI-D-13-00230 developing workable solutions for the multitude of edentulous patients. I took keen notice of how he simply and predictably restored full arches with the ramus blade, ramus frame, anterior segment, and STR dental implants. The genius is in the simplicity! Dr Roberts solved, in an uncomplicated manner, many problems that we still have with root forms by using blade dental implants. By presenting several histology studies performed by Dr. Leonard I. Linkow, I made the point that blade forms osseointegrated. I presented several of my cases with over 18 years of service in atrophic bone, with some cases utilizing preangled STR blades in lieu of sinus augmentation. The preangled STR transforms treating the vexing posterior maxilla into an easily and quickly restorable region. I also presented a time and cost comparison of blade form verses root form cases and the parameters that assure success of blade form cases. Dr Roberts and I both made the case that the art of blade form implants can be taught to motivated and skilled dentists, be predictably placed and restored, and that blade form dental implants have passed the test of time. Blade form dental implants can be used in areas where root forms are placed, but they are a game changer in the atrophic ridge where many times questionable, extensive, and expensive bone grafting is employed with associated morbidity. I am of the opinion that a true oral implantologist knows how and when to place and restore blade form and subperiostal dental implants in addition to root forms. Hopefully this decision is a turning point for implant dentistry! I thank the following doctors, with whom I conferred in preparation for this endeavor: Cindy Vu, C. Benson Clark, Raul Mena, Wayne O’Roark, Jack E. Lemons, and John Brunski. I am especially grateful to Dr Leonard I. Linkow for being my dental implantology mentor and his suggestions Journal of Oral Implantology 523

Table of Contents for the Digital Edition of Journal of Oral Implantology October 2013

Food and Drug Administration: Reclassification of Blade Form Dental Implants
Optimizing Platelet-Rich Plasma Gel Formation by Varying Time and Gravitational Forces During Centrifugation
Effect of Surface Roughness and Low-Level Laser Therapy on Removal Torque of Implants Placed in Rat Femurs
Impression Techniques for Multiple Implants: A Photoelastic Analysis. Part I: Comparison of Three Direct Methods
Impression Techniques for Multiple Implants: A Photoelastic Analysis. Part II: Comparison of Four Acrylic Resins
A Pig Model for the Histomorphometric Evaluation of Hard Tissue Around Dental Implants
In Situ Tooth Replica Custom Implant: A 3-Dimensional Finite Element Stress and Strain Analysis
Influence of Different Soft Liners on Stress Distribution in Peri-Implant Bone Tissue During Healing Period. A 3D Finite Element Analysis
Influence of Surface Nano-Roughness on Osseointegration of Zirconia Implants in Rabbit Femur Heads Using Selective Infiltration Etching Technique
Modified Titanium Surfaces Alter Osteogenic Differentiation: A Comparative Microarray- Based Analysis of Human Mesenchymal Cell Response to Commercial Titanium Surfaces
Hemorrhage Secondary to Interforaminal Implant Surgery: Anatomical Considerations and Report of a Case
Rehabilitation of a Patient With Mandibular Resection Using Osteointegrated Implants: A Case Report
Two-Stage Bone Expansion Technique Using Spear-Shaped Implants Associated With Overlapped Flap: A Case Report
Implant Esthetic Restoration in Ridge Deficiencies in Cases of Trauma: A Case Report
Rehabilitation of the Atrophic Maxilla With Tilted Implants: Review of the Literature

Journal of Oral Implantology October 2013