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Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
Bicon has been in operation since June 1994. Prior to Bicon, its main product line was under the ownership of two other entities, Driskell Bioengineering (1985–1987) and Stryker Corporation (1988–1994) of Kalamazoo Michigan. The following section briefly describes the history of the Bicon company and the dental implant products that it offers.
The Automatic Complaint-Letter Generator is a website that automatically generates complaint letters. The website was created by Scott Pakin in 1994. The website was created by Scott Pakin in 1994. It allows users to submit the name of the individual or company that the complaint is directed toward.
The basis for modern dental implants is a biological process called osseointegration, in which materials such as titanium or zirconia form an intimate bond to the bone. [1] The implant fixture is first placed so that it is likely to osseointegrate, then a dental prosthetic is added.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
In October 2013, the FDA stated that since the product was approved in 2002 it had received 943 reports of adverse events related to Essure, mainly for pain (606 of the complaints). [5] An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obliged to report complaints.
While most insurers require upfront payment and filing for reimbursement, some offer direct vet payments. Investigate the average processing time and the company's claim approval rate.
Therefore every implant is unique. As an optimised root-form it is much more than a simple 1:1 replica of a tooth. Since it exactly fills the gap left after the tooth is extracted, surgery is rarely needed. The implant can be produced from a copy of the extracted tooth, an impression of the tooth socket, or from a CT scan or CBCT scan. [8]