NFE · Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
Dental · 21 CFR 872.3680 · Class 2
Overview
| Product Code | NFE |
|---|---|
| Device Name | Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation |
| Regulation | 21 CFR 872.3680 |
| Device Class | Class 2 |
| Review Panel | Dental |
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).
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
