← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K002452

# 3M RELY X VENEER CEMENT TRY-IN PASTER (K002452)

_3M Company · EMA · Sep 28, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K002452

## Device Facts

- **Applicant:** 3M Company
- **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md)
- **Decision Date:** Sep 28, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K002452](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K002452)

**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
