# Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
> **Food and Drug Administration** · Final order. · Published 2013-12-30 · Effective 2013-12-30 · 78 FR 79308
## Document
- **Document number:** 2013-31217
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 79308
- **CFR reference:** 21 CFR 872
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/12/30/2013-31217/dental-devices-reclassification-of-temporary-mandibular-condyle-prosthesis)
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