21 CFR 872.3890 — Splint, Endodontic Stabilizing
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3890
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELS | Splint, Endodontic Stabilizing | 2 | 6 |
Special Controls
ELS — Splint, Endodontic Stabilizing
*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.
eCFR
