Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments

FDA Issues Guidance Establishing Special Controls for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments
Document issued on : May 12, 2004
The draft of this document was issued on May 14, 2002
This document supersedes:
Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA issued May 14, 2002
Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; Final, 04/21/1999
Information Necessary for Premarket Notification Submissions For Screw-Type Endosseous Implants, 12/09/1996
Guidance For the Arrangement and Content of a Premarket Approval (PMA) Application for An Endosseous Implant For Prosthetic Attachment, 5/16/89
(parts of) Calcium Phosphate(Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants, 2/21/97
For questions regarding this document, contact Angela Blackwell at (301) 827-5283 ext 119 or by email at AEB@cdrh.fda.gov
The document describes ways in which manufacturers of endosseous dental implants, fixtures surgically implanted into a patientÇƒÙs bone, and endosseous dental implant abutments, used with the root-form endosseous dental implant, may comply with the class II special controls.
Introduction
This guidance document was developed as a special control guidance to support the reclassification of the root-form endosseous dental implant device into class II and the reclassification of the endosseous dental implant abutment device into class II. FDA is issuing this guidance in conjunction with a Federal Register notice announcing the final rule reclassifying these device types. Blade-form endosseous dental implants will remain in class III and are not within the scope of this guidance.
Root-form endosseous dental implant devices are characterized by four geometrically distinct types: basket, screw, solid cylinder, and hollow cylinder. The root-form endosseous dental implant device refers to the fixture that is surgically implanted into the patientÇƒÙs bone. The root-form endosseous dental implant device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore the patientÇƒÙs chewing function.
The endosseous dental implant abutment device is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. After the root-form endosseous dental implant is surgically placed and has healed, the endosseous dental implant abutment device is permanently attached to it in a second surgical procedure. The endosseous dental implant abutment extends above the gum, i.e., it is the transgingival component, which serves as the support for the artificial tooth or other prosthetic. However, if the endosseous dental implant includes an integral transgingival component, it does not need to be used with an abutment.
Following the effective date of the final rule reclassifying these devices, any firm submitting a 510(k) for a root-form endosseous dental implant device or endosseous dental implant abutment device will need to address the issues covered in this special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.