← Product Code [KIF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF) · K962885

# SEALEX EXTRA ROOT CANAL SEALER (K962885)

_Baladent · KIF · Aug 30, 1996 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K962885

## Device Facts

- **Applicant:** Baladent
- **Product Code:** [KIF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF.md)
- **Decision Date:** Aug 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3820
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K962885](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K962885)

**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