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: erhughesdds@aol.com
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
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