← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K024287

# FIXOBRIDGE 3-CEMENT (K024287)

_Advanced Healthcare , Ltd. · EMA · Mar 21, 2003 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K024287

## Device Facts

- **Applicant:** Advanced Healthcare , Ltd.
- **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md)
- **Decision Date:** Mar 21, 2003
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3275
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Indications for Use

A temporary cement for fixing dental bridges, temporary crowns or bridges, and all metal, porcelain and acrylic crowns.

## Device Story

Fixobridge 3-Cement is a dental material used by dentists for temporary fixation of dental prosthetics. It serves as a temporary cement for bridges, temporary crowns, and various crown types (metal, porcelain, acrylic). The device is applied by a clinician in a dental office setting to secure temporary restorations during the interim period before permanent cementation. It facilitates patient comfort and function while protecting the prepared tooth structure.

## Clinical Evidence

No clinical data provided; substantial equivalence based on device classification and intended use.

## Technological Characteristics

Dental cement classified under 21 CFR 872.3275 (Product Code: EMA).

## 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.

## Submission Summary (Full Text)

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4/28/03

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K024287](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K024287)

**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).

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