Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
other · Food and Drug Administration · Rule · Published 2013-12-30 · Effective 2013-12-30 · 78 FR 79308
Document
Document number
2013-31217
Federal Register citation
78 FR 79308
CFR reference
21 CFR 872
Type
Rule
Action
Final order.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2013-12-30
Effective date
2013-12-30
HHS docket
Docket No. FDA-2012-N-1239
Abstract
The Food and Drug Administration (FDA) is issuing a final 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 special controls guideline entitled "Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline" that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.