21 CFR §872.3890
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)Identification. An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.
- (b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.