Journal of Oral Implantology December 2013 - (Page 633)

EDITORIAL Blade-Form Dental Implants: FDA Reclassification as a Class II Dental Implant Device T he US Food and Drug Administration (FDA) provides guidance on the regulatory controls needed to reasonably assure the public regarding the safety and effectiveness of dental devices. The device regulatory pathways consist of three categories: Class I (general controls), Class II (special controls), and Class III (premarket approval). In January 2013, the FDA proposed reclassifying bladeform endosseous dental implants from a Class III device to a Class II device. The Class III regulatory pathway traditionally consists of extensive preclinical studies and multi-centered double-blinded clinical trials that involve considerable time and expense. The Class II pathway involves a 510k clearance, where the manufacturer's obligation is to demonstrate ''substantial equivalence'' to an existing Class II cleared device. Traditionally, a 510k clearance involves less time and expense than a premarket approval. The May 28, 1976, Section 513 amendment of the Food, Drug, and Cosmetic Act (FD&C Act), designated that devices in commercial distribution prior to the enactment of the amendments would be classified based upon a 3 step process. 1) recommendation from an FDA device classification advisory panel, 2) publication of the panel's recommended regulatory designation for comment, and 3) publication of the panel's final designated regulatory pathway. On December 20, 1980, all dental implants (regardless of geometry) were given a Class III designation. Section 513(e) of the FD&C Act was amended on July 9, 2012, to allow for the reclassification of classified preamendment devises by administrative order based upon ''new information.'' New information could be the result of reevaluating data given the FDA when the device was originally classified, plus information not presented, available, or developed at the time of the original DOI: 10.2350/AAID-JOI-D-13-Editorial.3906 classification (http://www.gpo.gov/fdsys/pkg/ FR-2013-01-14/html/2013-00388.htm). In 1998, the FDA formed a reclassification panel and found sufficient clinical information had been presented to warrant reclassification of root-form implants, implants with special retention features, and temporary implants as Class II devices. Therefore, root-form dental implants would henceforth require the less burdensome 510k regulatory pathway. The panel also stated, ''sufficient evidence had not yet been presented to reclassify blade-form endosseous dental implants to Class II.'' In 2009, the FDA requested that information for reclassification of blade-form implants be submitted, but only one device manufacturer responded. Unfortunately, the information submitted related to other types of dental implants and was not relevant to the reclassification issue. On January 14, 2013, the FDA, through its own initiative and based on new information proposed to reclassify the blade-form endosseous dental implant. The FDA requested that comments on this proposal be submitted by April 15, 2013. Two American Academy of Implant Dentistry Fellows/American Board of Oral Implantology Diplomates provided comments and on July 18, 2013, presented before the FDA.1 Edward Hughes, DDS, and Ralph Roberts, DDS, provided information which assisted the FDA in concluding: 1) The available scientific evidence supports a reasonable assurance of safety and effectiveness for the use of endosseous dental implants (blade-form) for restoration of chewing function; 2) the proposed special controls can be established; and 3) there is not an unreasonable risk of illness or injury for the endosseous dental implants (blade-form) when general and special controls are applied (http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/ DentalProductsPanel/UCM360930.pdf). There is current best evidence to support this reclassification of blades. In 1996, Steflik et al2 Journal of Oral Implantology 633 http://www.gpo.gov/fdsys/pkg/FR-2013-01-14/html/2013-00388.htm http://www.gpo.gov/fdsys/pkg/FR-2013-01-14/html/2013-00388.htm http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM360930.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM360930.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM360930.pdf http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/DentalProductsPanel/UCM360930.pdf

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

Blade-Form Dental Implants: FDA Reclassification as a Class II Dental Implant Device
Effect of Different Storage Media on the Regenerative Potential of Autogenous Bone Grafts: A Histomorphometrical Analysis in Rabbits
Tensile Resistance of Mineralized and Demineralized Rat Bones in Different Regions (Calvarial and Femur)
Microbial Diversity of Peri-Implant Biofilms on Implant Fixed Bar and Telescopic Double Crown Attachments
Evidence-Based Techniques to Assess the Performance of Dental Implants
Influence of Platform and Abutment Angulation on Peri-Implant Bone. A Three- Dimensional Finite Element Stress Analysis
Direct Current Electric Stimulation in Implant Osseointegration: An Experimental Animal Study With Sheep
Prevalence of Sinus Augmentation Associated With Maxillary Posterior Implants
The Bactericidal Effects of an Acidified Sodium Chlorite-Containing Oral Moisturizing Gel: A Pilot Study
Influence of Fine Threads and Platform-Switching on Crestal Bone Stress Around Implant— A Three-Dimensional Finite Element Analysis
An Evaluation of the Resonance Frequency Analysis Device: Examiner Reliability and Repeatability of Readings
Histologic and Histomorphometric Assessment of Implants and Periapical Tissues When Placed in the Sockets of Extracted Teeth, Teeth With Periapical Lesions, and Healed Lesions: A Canine Study
Microbiological Aspects of Human Mandibular Subperiosteal Dental Implants
A Technique for Removal of a Fractured Implant Abutment Screw
Eight-Year Results of Site Retention of Anorganic Bovine Bone and Anorganic Bovine Matrix
A Reactive Lesion (Pyogenic Granuloma) Associated With Dental Implant: A Case Report
Twelve-Year Clinical and Radiological Results of Maxillary and Mandibular Implant- Retained Bar Overdentures Carried out on Oxidized (TiUnite) Replace Select Implants: A Clinical Case
PEEK Dental Implants: A Review of the Literature

Journal of Oral Implantology December 2013