Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3890](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3890) → ELS — Splint, Endodontic Stabilizing

# ELS · Splint, Endodontic Stabilizing

_Dental · 21 CFR 872.3890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS

## Overview

- **Product Code:** ELS
- **Device Name:** Splint, Endodontic Stabilizing
- **Regulation:** [21 CFR 872.3890](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3890)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K972985.md) | SPLINT IT | Jeneric/Pentron, Inc. | Sep 24, 1997 | SESE |
| [K961704](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K961704.md) | MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM | Dentatus USA , Ltd. | Jul 26, 1996 | SESE |
| [K922673](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K922673.md) | FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING | Glasspan, Inc. | Feb 25, 1994 | SESE |
| [K834363](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K834363.md) | ENDIX RADICULAR BIOCERAMIC PIN | C.B.S. Biotechnics, Inc. | Feb 27, 1984 | SESE |
| [K811209](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K811209.md) | JACOB WIRZ TRANSFIXATION PIN | Colmed, Ltd. | Jun 16, 1981 | SESE |
| [K801525](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K801525.md) | ZEST ENDODONTIC STABILIZER | Zest Anchors, Inc. | Jul 21, 1980 | SESE |

## Top Applicants

- C.B.S. Biotechnics, Inc. — 1 clearance
- Colmed, Ltd. — 1 clearance
- Dentatus USA , Ltd. — 1 clearance
- Glasspan, Inc. — 1 clearance
- Jeneric/Pentron, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com