Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3810](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3810) → ELR — Post, Root Canal

# ELR · Post, Root Canal

_Dental · 21 CFR 872.3810 · Class 1_

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

## Overview

- **Product Code:** ELR
- **Device Name:** Post, Root Canal
- **Regulation:** [21 CFR 872.3810](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3810)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

## Classification Rationale

Class I (general 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 (20 of 35)

Showing 20 most recent of 35 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060075](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K060075.md) | FIBER-METAL POST | Foremost Dental, LLC | Mar 30, 2006 | SESE |
| [K042848](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K042848.md) | FRC POSTEC PLUS | Ivoclar Vivadent, Inc. | Nov 22, 2004 | SESE |
| [K030820](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K030820.md) | EVERSTICK POST | Stick Tech , Ltd. | May 20, 2003 | SESE |
| [K020431](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K020431.md) | FIBIOCORE | Est. Anthogyr | Jul 3, 2002 | SESE |
| [K012496](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K012496.md) | CARBON POST | J. Morita USA, Inc. | May 17, 2002 | SESE |
| [K013802](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K013802.md) | FRC POSTEC | Ivoclar Vivadent, Inc. | May 1, 2002 | SESE |
| [K012849](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K012849.md) | GLASS POST | J. Morita USA, Inc. | Mar 27, 2002 | SESE |
| [K012354](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K012354.md) | SNOWPOST, SNOWLIGHT | Danville Materials, Inc. | Oct 10, 2001 | SESE |
| [K003221](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K003221.md) | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | Oct 25, 2000 | SESE |
| [K003219](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K003219.md) | HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | Oct 25, 2000 | SESE |
| [K993545](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K993545.md) | TENAX WHITE POST | Coltene/Whaledent, Inc. | Apr 14, 2000 | SESE |
| [K000311](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K000311.md) | PARAPOST FIBER WHITE | Coltene/Whaledent, Inc. | Mar 14, 2000 | SESE |
| [K983266](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K983266.md) | FIBREKOR POST SYSTEM | Jeneric/Pentron, Inc. | Nov 9, 1998 | SESE |
| [K983161](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K983161.md) | KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC | Sabre-K , Ltd. | Sep 30, 1998 | SESE |
| [K974649](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K974649.md) | BIO-POST DENTAL POST SYSTEM | Advanced Aeromedical, Inc. | May 1, 1998 | SESE |
| [K972875](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K972875.md) | COSMOPOST | Ivoclar North America, Inc. | Sep 17, 1997 | SESE |
| [K945370](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K945370.md) | C-POST | Bisco, Inc. | Mar 31, 1995 | SESE |
| [K950213](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K950213.md) | THE STERN ROOT ANCHOR SYSTEM | Sterngold/Implamed | Mar 23, 1995 | SESE |
| [K942528](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K942528.md) | INTEGRAPOST | Dental Logics, Inc. | Aug 5, 1994 | SESE |
| [K942521](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K942521.md) | CONSERVA POST SYSTEM | Bull Frog Mfg. Co. | Jul 8, 1994 | SESE |

## Top Applicants

- J. Morita USA, Inc. — 3 clearances
- Harald Nordin S.A — 3 clearances
- Coltene/Whaledent, Inc. — 3 clearances
- Ivoclar Vivadent, Inc. — 2 clearances
- Ivoclar North America, Inc. — 2 clearances

---

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

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