Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3275](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3275) → EMA — Cement, Dental

# EMA · Cement, Dental

_Dental · 21 CFR 872.3275 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/EMA

## Overview

- **Product Code:** EMA
- **Device Name:** Cement, Dental
- **Regulation:** [21 CFR 872.3275](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3275)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Zinc oxide-eugenol: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. Dental cement other than zinc oxide-eugenol: Class II.

## Recent Cleared Devices (20 of 505)

Showing 20 most recent of 505 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254109](/device/K254109.md) | G-CEM UNIVERSAL | GC America, Inc. | May 18, 2026 | SESE |
| [K253337](/device/K253337.md) | REGEN Bioactive Cement | Inter-Med, Inc. | Apr 15, 2026 | SESE |
| [K252606](/device/K252606.md) | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | Mar 20, 2026 | SESE |
| [K254063](/device/K254063.md) | iCEM Universal Plus | Kulzer, LLC | Dec 19, 2025 | SESE |
| [K252785](/device/K252785.md) | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | Dec 12, 2025 | SESE |
| [K252808](/device/K252808.md) | GlasIonomer FX-LC | Shofu Dental Corporation | Dec 9, 2025 | SESE |
| [K252165](/device/K252165.md) | ZIRCONOMER P | Shofu Dental Corporation | Oct 28, 2025 | SESE |
| [K250953](/device/K250953.md) | EQUIA LC ONE | GC America, Inc. | Sep 19, 2025 | SESE |
| [K251775](/device/K251775.md) | RODIN Cement | Belport Company, Inc., Gingi-Pak | Sep 2, 2025 | SESE |
| [K251470](/device/K251470.md) | ResiCem EX | Shofu Dental Corporation | Jul 11, 2025 | SESE |
| [K250156](/device/K250156.md) | Choice 2 DC | Bisco, Inc. | Jul 11, 2025 | SESE |
| [K250566](/device/K250566.md) | EsCem RMGI | Spident Co., Ltd. | Jun 20, 2025 | SESE |
| [K242366](/device/K242366.md) | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | Jan 10, 2025 | SESE |
| [K240714](/device/K240714.md) | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | Jul 24, 2024 | SESE |
| [K241204](/device/K241204.md) | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | Jun 28, 2024 | SESE |
| [K240888](/device/K240888.md) | Calibra Abutment Resin Cement | Dentsply Sirona | Apr 2, 2024 | SESE |
| [K233161](/device/K233161.md) | BeautiLink SA | Shofu Dental Corporation | Sep 28, 2023 | SESE |
| [K231552](/device/K231552.md) | Dia-Cem | DiaDent Group International | Jul 28, 2023 | SESE |
| [K214076](/device/K214076.md) | EsCem | Spident Co., Ltd. | Dec 19, 2022 | SESE |
| [K222253](/device/K222253.md) | GlasIonomer FX ULTRA | Shofu Dental Corporation | Sep 22, 2022 | SESE |

## Top Applicants

- GC America, Inc. — 30 clearances
- Voco GmbH — 26 clearances
- Dentsply Intl. — 19 clearances
- Shofu Dental Corp. — 16 clearances
- 3M Company — 12 clearances

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**Source:** [https://fda.innolitics.com/productcode/EMA](https://fda.innolitics.com/productcode/EMA)

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