Docket Management
Docket: 02N-0114 - Reclassification of Root-Form Endosseous Dental Implants & Endosseous Dental Implant Abutments
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Bruce Hollander Date/Time 2002-07-31 10:17:04
Organization Bio-Lok International, Inc.
Category Company

Comments for FDA General
1. General Comments Dear Sirs: After working in the field of dental implantology for 6 years and seeing what truly is going on, not necessarily what is reported to the FDA, I believe it would be a mistake to reclassify endosseous dental implants from Class III to Class II. There isn't stringent enough examination and reporting on the surfaces of dental implants now, less would be intolerable. There are major companies that used to be able to brag about 98% success rates that today are having their implants falling out of peoples mouths due to infections caused by initial contamination of the implant at placement. These cases are not the doctor's fault, but the manufacturers fault. Give these companies more latitude and the health and welfare of many patients will be compromised; far more than exist today. I believe it is the FDA's responsibility to thwart manufactures' attempts to cut costs at the expense of patient health. The loss of an implant or a number of implants, by infection caused by contamination 5-7 years after placement, eliminates that patient's chance for a more enriched life. They must return to alternatives that are not acceptable, reclassify to Class II will allow many unqualified companies to participate in the industry and turn Implant Dentistry into a major cause of oral infection. On the other hand, I take no exception to the reclassification of abutments to Class II. Implants and healing abutments, both of which go into an open wound should be maintained as Class III and all other implant prosthetic abutments should be reclassified to Class II. Thank you for your consideration.

EC -1