ENDIX RADICULAR BIOCERAMIC PIN
Device Facts
| Record ID | K834363 |
|---|---|
| Device Name | ENDIX RADICULAR BIOCERAMIC PIN |
| Applicant | C.B.S. Biotechnics, Inc. |
| Product Code | ELS · Dental |
| Decision Date | Feb 27, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3890 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
