21 C.F.R. § 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.
Notes of Decisions
Cited in 3
cases, 1993–1996 · leading case: Lamontagne v. EI Du Pont De Nemours & Co., 834 F. Supp. 576 (D. Conn. 1993).
Lamontagne v. EI Du Pont De Nemours & Co., 834 F. Supp. 576 (D. Conn. 1993). “12, 1987); 21 C.F.R. § 872.3680 (1992). The General and Plastic Surgery Device Classification Panel and the Ear, Nose and Throat Device Classification Panel also each reviewed the PTFE material for use in areas appropriate to their respective medical specialties and recommended…”
Anguiano v. E.I. Du Pont de Nemours & Co., 44 F.3d 806 (9th Cir. 1995). “21 C.F.R. § 872.3680 . Because of the more extensive requirements imposed on Class III devices, the MDA preempts state law regarding a Class III device even if the only MDA regulation specifically addressing the device is an identification regulation.”
Kealoha v. E.I. du Pont de Nemours & Co., 82 F.3d 894 (9th Cir. 1996). “As this court- concluded in Anguiano: There is no federal preemption here because the FDA has issued only identification and classification regulations relating to PTFE vitreous carbon material, 21 C.F.R. § 872.3680 ,- mandibular implant facial prosthesis, 21 C.”
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