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.

Organization

Country / Region

United States

License

Other (Public Domain)

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