CDRH Posts Proposed Rule, Guidance on Dental Implant

CDRH Posts Proposed Rule, Guidance on Dental Implant
Entire report can be viewed online.
CDRH posted a proposed rule on reclassification of root-form endosseous dental implants and endosseous dental implant abutments. CDRH also posted a draft guidance on Class II Special Controls for the implants. Comments on both the proposed rule and draft guidance are due 12 August.
When final this document will supersede:
-Overview of Information Necessary for Premarket Notification Submissions for
Endosseous Implants; Final, 04/2 l/l 999
-Information Necessary for Premarket Notification Submissions For Screw-Type
Endosseous Implants, 12/09/l 996
-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-(parts of) Calcium Phosphate(Ca-P) Coating Draft Guidance for Preparation of FDA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, 2/2 l/97
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Dental Device Branch
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation