Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
Information
Type
Proposed Rule
Regulated products
Published
February 7, 2013
Last updated
February 7, 2013
Description
Document number 2013-02688. The Food and Drug Administration (FDA) is issuing a proposed order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device "temporary mandibular condyle reconstruction plate." FDA is also issuing the draft special controls guideline, "Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate," which sets forth the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)