ELS · Splint, Endodontic Stabilizing
Dental · 21 CFR 872.3890 · Class 2
Overview
| Product Code | ELS |
|---|---|
| Device Name | Splint, Endodontic Stabilizing |
| Regulation | 21 CFR 872.3890 |
| Device Class | Class 2 |
| Review Panel | Dental |
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.
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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972985 | SPLINT IT | Jeneric/Pentron, Inc. | Sep 24, 1997 | SESE |
| K961704 | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | Dentatus USA , Ltd. | Jul 26, 1996 | SESE |
| K922673 | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. | Feb 25, 1994 | SESE |
| K834363 | ENDIX RADICULAR BIOCERAMIC PIN | C.B.S. Biotechnics, Inc. | Feb 27, 1984 | SESE |
| K811209 | JACOB WIRZ TRANSFIXATION PIN | Colmed, Ltd. | Jun 16, 1981 | SESE |
| K801525 | ZEST ENDODONTIC STABILIZER | Zest Anchors, Inc. | Jul 21, 1980 | SESE |
Top Applicants
- Zest Anchors, Inc. — 1 clearance
- Jeneric/Pentron, Inc. — 1 clearance
- Glasspan, Inc. — 1 clearance
- Dentatus USA , Ltd. — 1 clearance
- Colmed, Ltd. — 1 clearance
