21 CFR 872.4770
§ 872.4770 Temporary mandibular condyle reconstruction plate.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.4770, § 872.4770 Temporary mandibular condyle reconstruction plate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90139
- Permanent ID
ys:prov:90139@1- SHA-256
a8bf62a991b035fb79eb03e714f92135be0a55f9f1ce42741963c53c9afeef2d
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Full text
(a) Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.
(b) Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.