21 C.F.R. § 872.3680

Current through March 31, 2024
Section 872.3680 - Polytetrafluoroethylene (PTFE) vitreous carbon materials
(a)Identification. Polytetrafluoroethylene (PTFE) vitreous carbon material is a device composed of polytetrafluoroethylene (PTFE) vitreous carbon intended for use in maxillofacial alveolar ridge augmentation (building up the upper or lower jaw area that contains the sockets in which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth are rooted) or the temporomandibular joints (the joint between the upper and lower jaws).
(b)Classification. Class II.

21 C.F.R. §872.3680

52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987