Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 872.3645 - Subperiosteal implant material.

(a) Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.
cite as: 21 CFR 872.3645