← Product Code [ELR](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR) · K003219

# HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST (K003219)

_Harald Nordin S.A · ELR · Oct 25, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K003219

## Device Facts

- **Applicant:** Harald Nordin S.A
- **Product Code:** [ELR](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR.md)
- **Decision Date:** Oct 25, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 872.3810
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K003219](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELR/K003219)

**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