Prosthetic devices · 21 CFR 872 Subpart D
Zinc Oxide Eugenol
FDA device type “Zinc Oxide Eugenol”.
- Companies listing it
- 6538 makers
- Brands and models
- 106
- 510(k) clearances
- 110 in five years
- FDA name
- Zinc Oxide Eugenol
510(k) clearances per year, 1976–2026
Companies that list EMB
65 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Temp Eugenol | 15 | 2026 |
| Voco GmbH | Germany | Maker | Provicol QM Plus | 117 | 2026 |
| DiaDent Group International | South Korea | Maker | DIACEM TEMPNE | 24 | 2026 |
| Sybron Dental Specialties | United States | Maker | Embonte · Temp-Bond Original | 203 | 2026 |
| Prevest Denpro Limited | India | Maker | Ziconol XS · Zinconol · Zitemp | 7 | 2024 |
| Pac-Dent Inc. | United States | Maker | Rodin InteCem Intermediate Restorative Material | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | ZINO-EG Zinc Oxide Eugenol Cement | 5 | 2022 |
| Keystone Industries | United States | Maker | Keystone Eugenol · Keystone Zinc Oxide Powder · Mizzy Z.O.E Cement | 2 | 2025 |
| J. Morita USA, Inc. | United States | Maker | Power Temp(TM) Temporary Cement | 42 | 2022 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | TempoCem AM Refill 1+40 USA · TempoCem-Smartmix USA | 4 | 2022 |
| Scientific Pharmaceuticals | United States | Maker | EUGENOL CLASSIC · ZNO | 73 | 2020 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime Dent Zinc Oxide Eugenol Cement · Prime Dent Zinc Oxide Eugenol Reinforced Cement · Prime Dent Zinc Phosphate Cement | 9 | 2012 |
| Psp Dental Co., Ltd. | United Kingdom | Maker | TEMPLIN, TEMP D, NUCAVFIL | 6 | 1986 |
| Silmet , Ltd. | Israel | Maker | ProZoe | 3 | 2011 |
| Advanced Healthcare , Ltd. | United Kingdom | Maker | AHL GENERIC REINFORCED ZINC OXIDE · EUGENOL CEMENT | 3 | 2003 |
| Dental Technologies, Inc. | United States | Maker | — | 2 | 2013 |
| Prestige Brands Holdings, Inc. | United States | Maker | Dentek Complete Dental Repair Kit · Dentek Dental First Aid Kit · Temparin Max Hold · Thin Set Cap and Crown Cement | 1 | 2013 |
| Seilglobal CO., Ltd | South Korea | Maker | ZirADD | 1 | 2015 |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | ZINC OXIDE EUGENOL | — | — |
| KI. Works Vietnam Co., Ltd. | Vietnam | Maker | CVS FLNG CRWN RPR 1CT - 695108 · CVS LST FL CR RPR 2CT - 572123 | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Zinc Oxide Eugenol | — | — |
| Produits Dentaires SA | Switzerland | Maker | EssenSeal · Eugenol · Zinc Oxide | — | — |
| Associated Dental Products Ltd | United Kingdom | Maker | Alganol Liquid 30ml · Alganol Powder 90g · Eugenol B.P. Liquid 150ml · Eugenol B.P. Liquid 30ml · +6 | — | — |
| Aadi Med Private Limited | India | Maker | ZOE Impression Paste, Zinc Oxide Powder, Eugenol, Ziego | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | Fill Canal · Provisory Temporary Cement · Surgical Cement | — | — |
| Viarden Lab LLC | United States | Maker | CRI INTERMEDIAL CEMENT VIARDEN LAB, VIAR PACK VIARDEN LAB · EUGENOL LIQUID VIARDEN LAB · OZE VIARDEN LAB, OZE TEMPORARY CEMENT | — | — |
| DOC BRANDS, Inc. | United States | Maker | Dental Cement · Dentemp · Temp-Fil | — | — |
| Nobil Metal S p A | Italy | Maker | NOBIL FIX · NOBIL GRIP | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | X-root Sealer Dental cement | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT TEMPORARY FILLING - 1DERFUL TEMPORARY FILLING | — | — |
| Conamco | United States | Maker | Medental | — | — |
| Global Dent Aids Pvt. Ltd. | India | Maker | DENTEMP | — | — |
| ChangShu ShangChi Dental Materials Co., Ltd. | China | Maker | Zinc Oxide Eugenol Cement | — | — |
| Shanghai Rong Xiang Dental Material Company Limited | China | Maker | M3 Naturals Ventures, LLC · NK | — | — |
| Iimed Medical Mexicana S. de R.L. de C.V. | Mexico | Maker | SUB1 TEMP MAX 2.64 | — | — |
| Ghimas SPA | Italy | Maker | — | — | — |
| DSI Dental Solutions Ltd | Israel | Manufacturer | Zoer Quick · ZOER Reinforced | 2 | 2025 |
| Pulpdent Corporation | United States | Manufacturer | EUGENOL · ZINC OXIDE | 107 | 2021 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex | 2 | 2014 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Calcium Hydroxide · ADS Eugenol · ADS Zinc Oxide · Dharma Calcium Hydroxide · +5 | 1 | 2015 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | EUGENOL · ZINC OXIDE EUGENOL | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | ZINC OXIDE EUGENOL | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Zinc Cement | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | IRM / Zoe Cement | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DiaCemTempNE | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Lena Ko Corporation | Taiwan | Foreign exporter | CVS FLNG CRWN RPR 1CT - 695108 · CVS LST FL CR RPR 2CT - 572123 | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | AxioIRM · AxioIRM XS · AxioZi-Temp | — | — |
| Zapalign LLC | United States | Repacker / relabeler | ZINC OXIDE EUGENOL | — | — |
| Diverge Group Inc | Hong Kong SAR China | Foreign exporter | — | — | — |
| Ki. WORKS VIETNAM CO., LTD | Hong Kong SAR China | Foreign exporter | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | ZINC OXIDE EUGENOL | — | — |
| Steel City Health Private Limited | India | Repacker / relabeler | Cavity Filler for Crowns & Bridge Work · Crowns, Fillings & Bridges · Cureforte - Dental Cement Kit Zinc Oxide Eugenol · Emergency Dental Care set · +3 | — | — |
| Jack Jack LLC | United States | Lister | JJ CARE Temporary Tooth Cement, Zinc Eugenol Powder & Liquid, Eugenol Cement, Zinc Oxide Eugenol | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Indivation Exports Private Limited | India | Repacker / relabeler | Mastermedi Zinc Oxide Eugenol Cement Dental Care Kit | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 15 Sep 2016 | K161630 | Provicol QM Plus | Voco GmbH |
| 12 Jun 2012 | K120695 | DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT | Dentist IN A Box Pty., Ltd. |
| 10 Jun 2011 | K110759 | TEMPOCEM | Dmg USA, Inc. |
| 31 Jan 2008 | K073539 | PROVISA CEM | Cavex Holland BV |
| 7 Mar 2002 | K020158 | NON-EUGENOL TEMPORARY CEMENT | J. Morita USA, Inc. |
| 24 May 1995 | K941066 | DENTAL 911 | L.A.F. Industries, Inc. |
| 23 Sep 1986 | K861681 | DENTIMEDIC DENTAL EMERGENCY KIT | Dentimedic |
| 31 Jul 1986 | K862745 | EUGENOL USP | E&D Dental Manufacturing Co. |
| 14 Jun 1982 | K821581 | DEN TEMP | Majestic Drug Co., Inc. |
| 7 Aug 1980 | K801779 | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT | Oxy Dental Products, Inc. |
| 3 Jan 1978 | K772315 | KWIKAP | Den-Mat Corp. |
Official records: FDA product classification for EMB · 21 CFR 872.3275.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026