EMA · Cement, Dental
Dental · 21 CFR 872.3275 · Class 2
Overview
| Product Code | EMA |
|---|---|
| Device Name | Cement, Dental |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 504)
Showing 20 most recent of 504 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | Apr 15, 2026 | SESE |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | Mar 20, 2026 | SESE |
| K254063 | iCEM Universal Plus | Kulzer, LLC | Dec 19, 2025 | SESE |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | Dec 12, 2025 | SESE |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | Dec 9, 2025 | SESE |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | Oct 28, 2025 | SESE |
| K250953 | EQUIA LC ONE | GC America, Inc. | Sep 19, 2025 | SESE |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | Sep 2, 2025 | SESE |
| K251470 | ResiCem EX | Shofu Dental Corporation | Jul 11, 2025 | SESE |
| K250156 | Choice 2 DC | Bisco, Inc. | Jul 11, 2025 | SESE |
| K250566 | EsCem RMGI | Spident Co., Ltd. | Jun 20, 2025 | SESE |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | Jan 10, 2025 | SESE |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | Jul 24, 2024 | SESE |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | Jun 28, 2024 | SESE |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | Apr 2, 2024 | SESE |
| K233161 | BeautiLink SA | Shofu Dental Corporation | Sep 28, 2023 | SESE |
| K231552 | Dia-Cem | DiaDent Group International | Jul 28, 2023 | SESE |
| K214076 | EsCem | Spident Co., Ltd. | Dec 19, 2022 | SESE |
| K222253 | GlasIonomer FX ULTRA | Shofu Dental Corporation | Sep 22, 2022 | SESE |
| K214118 | Riva Cem Automix | Sdi Limited | Aug 30, 2022 | SESE |
Top Applicants
- GC America, Inc. — 29 clearances
- Voco GmbH — 26 clearances
- Dentsply Intl. — 19 clearances
- Shofu Dental Corp. — 16 clearances
- Sybron Dental Specialties, Inc. — 12 clearances
