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/submissions/DE/subpart-d%E2%80%94prosthetic-devices/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 504) Showing 20 most recent of 504 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253337](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K253337.md) | REGEN Bioactive Cement | Inter-Med, Inc. | Apr 15, 2026 | SESE | | [K252606](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K252606.md) | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | Mar 20, 2026 | SESE | | [K254063](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K254063.md) | iCEM Universal Plus | Kulzer, LLC | Dec 19, 2025 | SESE | | [K252785](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K252785.md) | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | Dec 12, 2025 | SESE | | [K252808](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K252808.md) | GlasIonomer FX-LC | Shofu Dental Corporation | Dec 9, 2025 | SESE | | [K252165](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K252165.md) | ZIRCONOMER P | Shofu Dental Corporation | Oct 28, 2025 | SESE | | [K250953](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K250953.md) | EQUIA LC ONE | GC America, Inc. | Sep 19, 2025 | SESE | | [K251775](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K251775.md) | RODIN Cement | Belport Company, Inc., Gingi-Pak | Sep 2, 2025 | SESE | | [K251470](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K251470.md) | ResiCem EX | Shofu Dental Corporation | Jul 11, 2025 | SESE | | [K250156](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K250156.md) | Choice 2 DC | Bisco, Inc. | Jul 11, 2025 | SESE | | [K250566](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K250566.md) | EsCem RMGI | Spident Co., Ltd. | Jun 20, 2025 | SESE | | [K242366](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K240714.md) | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | Jul 24, 2024 | SESE | | [K241204](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K241204.md) | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | Jun 28, 2024 | SESE | | [K240888](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K240888.md) | Calibra Abutment Resin Cement | Dentsply Sirona | Apr 2, 2024 | SESE | | [K233161](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K233161.md) | BeautiLink SA | Shofu Dental Corporation | Sep 28, 2023 | SESE | | [K231552](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K231552.md) | Dia-Cem | DiaDent Group International | Jul 28, 2023 | SESE | | [K214076](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K214076.md) | EsCem | Spident Co., Ltd. | Dec 19, 2022 | SESE | | [K222253](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K222253.md) | GlasIonomer FX ULTRA | Shofu Dental Corporation | Sep 22, 2022 | SESE | | [K214118](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K214118.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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